MAUDE Adverse Event Report: SYNTHES GMBH 12.5MM REAMER HEAD FOR RIA 2 STERILE

Catalog Number	03.404.021S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/02/2023
Type of Reportable Event	Malfunction
Additional 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: d9: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.E3: reporter is a j&j sales representative.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 or Problem Description
It was reported that on (b)(6) 2023, the ria 2 was used to collect bone graft from the left femur.The reamer head was retrieved and noted to be broken.The connection point of the reamer head and ria shaft were broken off.The 2nd ria shaft was then used with a new reamer head and graft kit and the procedure was completed.However the 2nd ria shaft was also broken and stuck inside of the bone harvesting kit.Both reamer shafts are deemed broken and new disposables were opened.Procedure completed successfully with a thirty(30) minutes of surgical delay and the metal shavings were left in femoral canal.This report is for one (1) 12.5mm reamer head for ria 2 sterile.This is report 1 of 3 for complaint (b)(4).
Additional 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 sample revealed that the prongs at the end of 12.5mm reamer head for ria 2 sterile were broken.The broken fragments were not returned for evaluation.No other problem identified.A dimensional inspection was not performed as it is not applicable to the complaint condition.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to unintended forces.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 12.5mm reamer head for ria 2 sterile would contribute to the complained device issue.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Drawing/specifications reviewed 03_404_024 rev b current, a manufactured.Dimensional inspection: n/a.H4, h6 manufacturing location: supplier ¿ (b)(4)/ inspected and packaged by: monument, release to warehouse date: 18-mar-2021, expiration date: 28-feb-2031, part number: 03.404.021s, 12.5mm reamer head for ria 2-sterile, lot number: 91p9293 (sterile).Production order traveler met all inspection acceptance criteria.Packaging label logs (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 19639 supplied by was reviewed and determined to be conforming.This lot met all dimensional, visual, sterility and packaging criteria at the time of release with no issues documented during the inspection or release of the product that would contribute to this complaint condition.Component part(s) reviewed: part number: 03.404.M021, ria 2 reamer head 12.5mm, lot number: 7072002.Inspection instruction met all inspection acceptance criteria.Inspection sheet, incoming final inspection, ns073690 rev b met all inspection acceptance criteria.Certificate of compliance received and dated 21-aug-2020 was reviewed and determined to be conforming.Certification for heat treat supplied and dated 06-aug-2020 was reviewed and determined to be conforming.Heat treat specified at 50-55 hrc.Results certified at 54 hrc.Certificate of analysis supplied and dated 14-may-2020 was reviewed and determined to be conforming.Raw material certification supplied to banner medical from carpenter dated 28-apr-2020 was reviewed and determined to be conforming.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.
Additional 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.D4, h4, h6: device history record (dhr) review conducted: manufacturing location: supplier ¿ mark two engineering / inspected and packaged by: monument.Release to warehouse date: 18-mar-2021.Expiration date: 28-feb-2031.Part number: 03.404.021s, 12.5mm reamer head for ria 2-sterile.Lot number: 91p9293 (sterile).Lot quantity: (b)(4).Production order traveler met all inspection acceptance criteria.Packaging label logs (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 was reviewed and determined to be conforming.This lot met all dimensional, visual, sterility and packaging criteria at the time of release with no issues documented during the inspection or release of the product that would contribute to this complaint condition.Component part(s) reviewed: part number: 03.404.M021, ria 2 reamer head 12.5mm.Lot number: 7072002.Lot quantity: (b)(4).Inspection instruction met all inspection acceptance criteria.Inspection sheet, incoming final inspection, met all inspection acceptance criteria.Certificate of compliance dated 21-aug-2020 was reviewed and determined to be conforming.Certification for heat treat dated 06-aug-2020 was reviewed and determined to be conforming.Certificate of analysis dated 14-may-2020 was reviewed and determined to be conforming.Raw material certification dated 28-apr-2020 was reviewed and determined to be conforming.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.

• Brand Name: 12.5MM REAMER HEAD FOR RIA 2 STERILE
• Common Device Name: 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: 17445544
• Report Number: 8030965-2023-09698
• Device Sequence Number: 14086234
• Product Code: HTO
• UDI-Device Identifier: 10886982274007
• UDI-Public: (01)10886982274007
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: K111437
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 03.404.021S
• Device Lot Number: 91P9293
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/18/2023
• Supplement Date Received by Manufacturer: 08/21/2023; 09/19/2023
• Initial Report FDA Received Date: 08/02/2023
• Supplement Report FDA Received Date: 08/31/2023; 09/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/18/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DRIVE SHAFT FOR RIA 2 520MM; DRIVE SHAFT FOR RIA 2 520MM; RIA 2 BONE HARVESTING KIT 520MM STERILE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown