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

Model Number	03.404.000S
Medical Device Problem Codes	Mechanical Problem (1384); Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/16/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2023 during a stryker revision retrograde nail case, surgeon utilized ria2 to collect bone graft.During harvesting, the tubing became clogged with bone graft not allowing graft to be collected.The tubing was cut and clogged bone graft removed.Another ria2 kit was opened to continue graft collection.No further clogs occurred.The surgery was successfully completed without any surgical delay.No patient consequences was there.This report is for one (1) ria 2 bone harvesting kit 520mm sterile.This is report 1 of 1 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.H10 additional narrative: d2b: additional product code: e3: reporter is a j&j sales representative.H3, h4, h6.Manufacturing location: packaged, sterilized and released by: monument.Release to warehouse date: 11-jan-2023.Expiration date: 31-dec-2023.Part number: 03.404.000s, ria 2 bone harvesting kit 520mm sterile, lot number: 3750p62 (sterile).Production order traveler met all inspection acceptance criteria.Packaging label log (pll) lppf rev b, lmd rev b was reviewed and determined to be conforming.Packaging bom was reviewed and determined to be conforming.Scn supplied by jabil 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: 03.404m001, reaming rod/drive shaft packaged, lot number: 3580p62.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: 3670p02.Inspection instruction met all inspection acceptance criteria.Inspection sheet, incoming final inspection, (b)(6) rev a met all inspection acceptance criteria.Certificate of conformance supplied by rochling medical dated 06-dec-2022 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: 3673p79.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: 3834p71.Inspection instruction met all inspection acceptance criteria.Inspection sheet, incoming final inspection, (b)(6) rev a met all inspection acceptance criteria.Certificate of compliance supplied by harmac medical products dated 14-dec-2022 was reviewed and determined to be conforming.Part number: 03.404m015, suction tubing set, lot number: 3834p72.Inspection instruction met all inspection acceptance criteria.Inspection sheet, incoming final inspection, (b)(6) rev a met all inspection acceptance criteria.Certificate of compliance supplied by harmac medical products dated 14-dec-2022 was reviewed and determined to be conforming.Part number: 03.404m033, ria ii graft filter, lot number: 3575p96.Inspection instruction met all inspection acceptance criteria.Inspection sheet, incoming final inspection, (b)(6) rev d met all inspection acceptance criteria.Note: while no certificate of conformance supplied by rochling was found in the dhr, raw materials certifications from rochling sub-contractors were included.Part number: 03.404m003, manifold assembly packaged, lot number: 3752p23.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: 3465p44.Inspection instruction met all inspection acceptance criteria.Inspection plan, 03.404m010-2-btq957412 / 1, met all inspection acceptance criteria.Certificate of conformance supplied by rochling dated 22-nov-2022 was reviewed and determined to be conforming.Visual analysis of the returned sample revealed that ria 2 bone harvesting kit 520mm sterile the aspirator tube component was bent, kinked and broken, fragment is included in the evidence.A foreign substance can be observed at the tip of the tube.Additionally, the filter assembly is missing.A dimensional inspection for the ria 2 bone harvesting kit 520mm sterile was unable to be performed due to post-manufacturing damage and device design materials.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to unintended forces as mentioned in the event description.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 520mm sterile 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.Drawing/specifications reviewed: ria 2 boneharvesting kit 520mm sterile rev.A.Dimensional inspection: n/a.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: RIA 2 BONE HARVESTING KIT 520MM STERILE
• Common Device Name: ARTHROSCOPE
• 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 ; 3035526892
• MDR Report Key: 17201161
• Report Number: 8030965-2023-08047
• Device Sequence Number: 20499948
• Product Code: HRX
• UDI-Device Identifier: 10886982274236
• UDI-Public: (01)10886982274236
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2023
• Device Model Number: 03.404.000S
• Device Catalogue Number: 03.404.000S
• Device Lot Number: 3750P62
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/23/2023
• Initial Report FDA Received Date: 06/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/11/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown