MAUDE Adverse Event Report: SYNTHES GMBH RIA 2 BONE HARVESTING KIT 520MM STERILE; REAMER

Catalog Number 03.404.000S

Device Problems Break (1069); Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/30/2023

Event Type  malfunction  

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H1 additional narrative: a1: patient id: (b)(6).D2: additional procode: hrx.D9: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.E3: reporter is a synthes employee.H3, h6: the investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Device report from singapore reports an event as follows: it was reported that during a procedure on (b)(6) 2023, a reamer/irrigator/aspirator (ria) 2 tube assembly was used for reaming of a tibia shaft fracture.Resistance was felt upon reaming of 2/3 tibia.The tube assembly was then removed and checked.The tube assembly was twisted and torn.The surgeon proceed with the surgery using synream instead.Procedure was successfully completed with no delay.This report is for a ria 2 bone harvesting kit 520mm sterile.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H4 device history manufacturing location: packaged, sterilized and released by: monument, release to warehouse date: 17-oct-2022, expiration date: 01-oct-2023, part number: 03.404.000s, ria 2 bone harvesting kit 520mm sterile, lot number: 2460p46 (sterile), lot quantity: (b)(4).Production order traveler met all inspection acceptance criteria.Packaging label log (pll) was reviewed and determined to be conforming.Packaging bom was reviewed and determined to be conforming with no deviations to normal packaging identified.Scn 23726 supplied by jabil (abq) was reviewed and determined to be conforming.This lot met all visual, sterility and packaging criteria at the time of release with no issues documented during the packaging or release of the product that would contribute to this complaint condition.Component part(s) reviewed: part number: 03.404.M001, rmg rod/drive shaft packaged lot number: 2266p58 lot quantity: (b)(4).Production order traveler met all inspection acceptance criteria.Packaging bom was reviewed and determined to be conforming with no deviations to normal packaging identified.Part number: 03.404m012, ria ii ream rod/dr shaft seal lot number: a000311662 lot quantity: (b)(4).Inspection instruction met all inspection acceptance criteria.Inspection sheet, incoming final inspection, met all inspection acceptance criteria.Certificate of conformance supplied by rochling medical dated 21-dec-2021 was reviewed and determined to be conforming.Note: raw materials certifications from rochling sub-contractors were included in the dhr.Part number: 03.404m002, graft/irr/suction assembly lot number: 2459p53 lot quantity: (b)(4).Production order traveler met all inspection acceptance criteria.Packaging bom was reviewed and determined to be conforming with no deviations to normal packaging identified.Part number: 03.404m014, irrigation tubing set lot number: 1286p46 lot quantity: (b)(4).Inspection instruction met all inspection acceptance criteria.Inspection sheet, incoming final inspection, met all inspection acceptance criteria.Certificate of compliance supplied by harmac medical products dated 14-jul-2022 was reviewed and determined to be conforming.Part number: 03.404m015, suction tubing set lot number: 1390p40 lot quantity: (b)(4).Inspection instruction met all inspection acceptance criteria.Inspection sheet, incoming final inspection, ns073692 rev a met all inspection acceptance criteria.Certificate of compliance supplied by harmac medical products dated 21-jul-2022 was reviewed and determined to be conforming.Part number: 03.404m033, ria ii graft filter, lot number: 1177p58, lot quantity: (b)(4).Inspection instruction met all inspection acceptance criteria.Inspection sheet, incoming final inspection, met all inspection acceptance criteria.Certificate of conformance supplied by rochling dated 13-jul-2022 was reviewed and determined to be conforming.Note: raw materials certifications from rochling sub-contractors were included in the dhr.Part number: 03.404m003, manifold assembly packaged, lot number: 2267p32, lot quantity: (b)(4).Production order traveler met all inspection acceptance criteria.Packaging bom was reviewed and determined to be conforming with no deviations to normal packaging identified.Part number: 03.404m010, ria ii manifold assembly, lot number: 2331p62, lot quantity: (b)(4).Inspection instruction met all inspection acceptance criteria.Inspection sheet, incoming final inspection, met all inspection acceptance criteria.Certificate of conformance supplied by rochling dated 16-sep-2022 was reviewed and determined to be conforming.Note: raw materials certifications from rochling sub-contractors were included in the dhr.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H3, h4, h6: the product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the returned device found that the ria 2 bone harvesting kit l520 was found bent from the tube assembly.Also the tube shaft has a broken piece, the device presents signs and marks of normal usage like minor nicks and light scratches as part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed as the observed condition of the ria 2 bone harvesting kit l520 would contribute to the complained device issue.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history review (dhr): manufacturing location: packaged, sterilized and released by: monument, release to warehouse date: 17-oct-2022, expiration date: 01-oct-2023, part number: 03.404.000s, ria 2 bone harvesting kit 520mm sterile, lot number: 2460p46 (sterile), lot quantity: (b)(4).Production order traveler met all inspection acceptance criteria.Packaging label log (pll) was reviewed and determined to be conforming.Packaging bom was reviewed and determined to be conforming with no deviations to normal packaging identified.Scn supplied by jabil (abq) was reviewed and determined to be conforming.This lot met all visual, sterility and packaging criteria at the time of release with no issues documented during the packaging or release of the product that would contribute to this complaint condition.Component part(s) reviewed: part number: 03.404.M001, rmg rod/drive shaft packaged, lot number: 2266p58, lot quantity: (b)(4).Production order traveler met all inspection acceptance criteria.Packaging bom was reviewed and determined to be conforming with no deviations to normal packaging identified.Part number: 03.404m012, ria ii ream rod/dr shaft seal, lot number: a000311662, lot quantity: (b)(4).Inspection instruction met all inspection acceptance criteria.Inspection sheet, incoming final inspection met all inspection acceptance criteria.Certificate of conformance supplied by rochling medical dated 21-dec-2021 was reviewed and determined to be conforming.Part number: 03.404m002, graft/irr/suction assembly, lot number: 2459p53, lot quantity: (b)(4).Production order traveler met all inspection acceptance criteria.Packaging bom was reviewed and determined to be conforming with no deviations to normal packaging identified.Part number: 03.404m014, irrigation tubing set lot number: 1286p46 lot quantity: (b)(4).Inspection instruction met all inspection acceptance criteria.Inspection sheet, incoming final inspection met all inspection acceptance criteria.Certificate of compliance supplied by harmac medical products dated 14-jul-2022 was reviewed and determined to be conforming.Part number: 03.404m015, suction tubing set, lot number: 1390p40, lot quantity: (b)(4).Inspection instruction met all inspection acceptance criteria.Inspection sheet, incoming final inspection met all inspection acceptance criteria.Certificate of compliance supplied by harmac medical products dated 21-jul-2022 was reviewed and determined to be conforming.Part number: 03.404m033, ria ii graft filter, lot number: 1177p58, lot quantity: (b)(4).Inspection instruction met all inspection acceptance criteria.Inspection sheet, incoming final inspection met all inspection acceptance criteria.Certificate of conformance supplied by rochling dated 13-jul-2022 was reviewed and determined to be conforming.Note: raw materials certifications from rochling sub-contractors were included in the dhr.Part number: 03.404m003, manifold assembly packaged lot number: 2267p32 lot quantity: (b)(4).Production order traveler met all inspection acceptance criteria.Packaging bom was reviewed and determined to be conforming with no deviations to normal packaging identified.Part number: 03.404m010, ria ii manifold assembly lot number: 2331p62 lot quantity: (b)(4).Inspection instruction met all inspection acceptance criteria.Inspection sheet, incoming final inspection met all inspection acceptance criteria.Certificate of conformance supplied by (b)(4) dated 16-sep-2022 was reviewed and determined to be conforming.Note: raw materials certifications from rochling sub-contractors were included in the dhr.This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: h3, h6: the device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.If information is obtained that was not available for this medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: RIA 2 BONE HARVESTING KIT 520MM STERILE
• Type of Device: REAMER
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 17362494
• MDR Text Key: 319799705
• Report Number: 8030965-2023-09023
• Device Sequence Number: 1
• Product Code: HTO
• UDI-Device Identifier: 07612334142351
• UDI-Public: (01)07612334142351
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: K111437
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2023
• Device Catalogue Number: 03.404.000S
• Device Lot Number: 2460P46
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/17/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 24 YR
• Patient Sex: Female
• Patient Weight: 50 KG