MAUDE Adverse Event Report: SYNTHES GMBH RFNA/ 10MM/ 360MM/ STANDARD BEND/ STER; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	04.233.036S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	07/01/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Hold for kr 7/25.It was reported that on (b)(6) 2023, patient was treated with a 10x360mm rfna for a fracture above a 4.5 va-lcp curved condylar plate from a previous surgery approximately six months ago.Patient showed signs of healing medially when patient heard a pop.The nail broke at the fracture zone.Affected hardware was removed and the patient was revised to a larger diameter rfna with bone graft obtained from ria2.Non-union resulting in broken nail which was removed on (b)(6) 2023.Surgeon removed broken hardware and revised with bone grafting.There was patient consequences.This report involves one (1) rfna / 10mm / 360mm standard bend / sterile.This is report 1 of 1 for (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.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 not expected to be returned for manufacturer review/investigation.H3, h4, h6: manufacturing location: monument manufacturing date: 12-sep-2022 expiration date: unknown part number: 04.233.036s, rfn/10mm/360mm/ 5 degree bend/pe inlay/sterile lot number: 1261p41 (sterile) production order traveler met all inspection acceptance criteria.Inspection sheet, in-process / inspect dimensional / final, ns498968 rev d met all inspection acceptance criteria.Inspection sheet, rfn assembly inspection, met all inspection acceptance criteria.Packaging bom was reviewed and determined to be conforming with no deviations to normal packaging identified.The scn was reviewed and met specified dose ranges however, there was no linkage to specific lot numbers within the document.There was no pll included in this dhr.Therefore, the pll for this lot could not be reviewed and the expiration date could not be notated.This lot met all dimensional and visual criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.Component part(s) reviewed: part number: 04.233.124.2y, poly inlay retrograde femoral manufacturing location: brandywine lot number: 825p074 (b)(4) production order traveler met all inspection acceptance criteria apart from the one piece noted.Inspection sheet, met all inspection acceptance criteria.Part number: 04.233.124.2y, poly inlay retrograde femoral manufacturing location: brandywine lot number: 828p257 (b)(4) production order traveler met all inspection acceptance criteria.Inspection sheet, met all inspection acceptance criteria.Part number: 21131, tialv*ri13.00 lot number: 795p689 inspection instruction met all inspection acceptance criteria.Certified test report and certificate was reviewed and determined to be conforming.Lot summary report met all inspection acceptance criteria.Raw material receiving / putaway checklist met all inspection acceptance criteria.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.Product was not returned.Based on the information available, it has been determined that no corrective and 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.

• Brand Name: RFNA/ 10MM/ 360MM/ STANDARD BEND/ STER
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• 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: 17380659
• Report Number: 8030965-2023-09216
• Device Sequence Number: 6399021
• Product Code: HSB
• UDI-Device Identifier: 10886982289148
• UDI-Public: 10886982289148
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K201346
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial

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: 04.233.036S
• Device Lot Number: 1261P41
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/05/2023
• Initial Report FDA Received Date: 07/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/12/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 50 YR
• Patient Sex: Female