MAUDE Adverse Event Report: SYNTHES GMBH FEMORAL NECK SYSTEM INSERTION HANDLE; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Catalog Number	03.168.008
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/30/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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
Device report from (b)(6) reports an event as follows: it was reported that on (b)(6) 2021 that the aiming arm slipped out of the plate after inserting the femoral neck system (fns).The locking compression plate (lcp) screw was released and the aiming arm came away.The surgery was completed successfully with a five (5) minute delay.Concomitant device: unk - plates: trauma(part# unknown, lot# unknown, qty unknown).This report is for one (1) femoral neck system insertion handle.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.Investigation summary visual inspection: the complaint devices insert handle (product code: 03.168.008, lot number: 170435-105) was returned to cq west chester for investigation.During visual inspection, no issues were identified on the returned part that could have contributed to the complaint condition.Functional test: a functional test could not be performed as the device was not returned with a mating device for evaluation.Can the complaint be replicated with the returned device(s)? no, the complaint cannot be replicated as a functional test could not be performed.Document/specification review: based on the date of manufacture, the current and manufactured version of drawing were reviewed.Complaint confirmed: no, the complaint condition cannot be confirmed during physical device investigation.Conclusion: the insertion instrument was returned without a mating device to evaluate the allegation, hence the complaint was not confirmed.A definitive assignable root cause could not be determined from the available information.There was no indication that a design or manufacturing issue contributed to the complaint.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 lot part #: 03.168.008 lot #: 170435-105 manufacturing site: werk selzach supplier: leitner ag release to warehouse date: 30 aug 2018 a manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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.Corrected data: g1, h3, h6.

• Brand Name: FEMORAL NECK SYSTEM INSERTION HANDLE
• Common Device Name: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES ÖSTERREICH GMBH (PRODUKTION); eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12704166
• Report Number: 8030965-2021-09043
• Device Sequence Number: 1558542
• Product Code: KTT
• UDI-Device Identifier: 07611819657342
• UDI-Public: 07611819657342
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K172872
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2021

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 Catalogue Number: 03.168.008
• Device Lot Number: 170435-105
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/30/2021
• Supplement Date Received by Manufacturer: 11/17/2021
• Initial Report FDA Received Date: 10/27/2021
• Supplement Report FDA Received Date: 12/14/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/30/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - PLATES: TRAUMA
• Patient Sex: Unknown