MAUDE Adverse Event Report: SYNTHES GMBH 10MM TI CANN RETRO/ANTEGRADE FEMORAL NAIL-EX/360MM-STERILE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	04.013.452S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	09/02/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2022, there was a revision surgery of a retrograde/antegrade femoral nail.The device was explanted due to non-union of the bone.This report involves one 10mm ti cann retro/antegrade femoral nail-ex/360mm-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.Additional narrative: additional product codes: hwc.Complainant part is not expected to be returned for manufacturer review/investigation.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.
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.H6: manufacturing location: monument, manufacturing date: 09 november 2021, expiration date: 30 september 2030, part: 04.013.452s, 10mm ti cann retro/antegrade femoral nail-ex/360mm ¿ sterile lot: 468p898 (sterile), production order traveler met all inspection acceptance criteria.Inspection sheet, in process / inspect dimensional / final 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.Sterilization control number (scn) supplied by jabil (abq) was reviewed and determined to be conforming.This lot met all dimensional, visual, sterilization and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.Component part(s) reviewed: component parts were not reviewed as the reported complaint condition of ¿removal for an unknown reason¿ does not indicate breakage of the nail.Therefore, review of the raw material would not be pertinent to the reported complaint condition.The photo was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the device from the received images.Visual analysis of the photo revealed that there was no damage or defects with the 10 ti cann retro/antegrade fem nl/360-s, p/n: 04.013.452s.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was not confirmed for 10 ti cann retro/antegrade fem nl/360-s, p/n: 04.013.452s.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 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: 10MM TI CANN RETRO/ANTEGRADE FEMORAL NAIL-EX/360MM-STERILE
• 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: 15475210
• Report Number: 8030965-2022-07264
• Device Sequence Number: 19595663
• Product Code: HSB
• UDI-Device Identifier: 10886982087874
• UDI-Public: 10886982087874
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K033618
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,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?: No
• Operator of Device: Health Professional
• Device Model Number: 04.013.452S
• Device Catalogue Number: 04.013.452S
• Device Lot Number: 468P898
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/02/2022
• Supplement Date Received by Manufacturer: 10/11/2022
• Initial Report FDA Received Date: 09/24/2022
• Supplement Report FDA Received Date: 10/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/09/2021
• 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: UNK - SCREWS: TRAUMA
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 37 YR
• Patient Sex: Female