MAUDE Adverse Event Report: SYNTHES GMBH INSERTION HANDLE FOR SUPRAPATELLAR; NAIL, FIXATION, BONE

Model Number	03.010.440
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/28/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2022 after inserting a tibial nail ex with proximal bend through a suprapatellar approach, the connecting screw that attached the suprapatellar insertion handle to the tibial nail would not loosen, and appeared that it was "spinning" inside the handle.There was a 25 minutes surgical delay.Procedure and patient outcome were unknown.This report is for one (1) insertion handle for suprapatellar.This is report 2 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Complainant part is not expected to be returned for manufacturer review/investigation.Occupation: reporter is a j&j sales representative.Contact office: postal code- (b)(6).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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: d4.Lot and expiration date.D9.Date device returned to manufacturer.H3.Device evaluated by manufacturer.H4.Device manufacture date.H3, h6: the device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: h6: part# 03.010.440, lot# 170326-101, manufacturing site: werk selzach logistik, release to warehouse date: 28 sep 2017, supplier: (b)(4), expiration date: n/a.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.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 insertion handle for suprapatellar had no signs of damage or defects.A dimensional inspection was performed for the insertion handle for suprapatellar and met specifications.A functional test was unable to be performed due the mating device was not returned.The complaint condition was not able to be replicated.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was not confirmed as the observed condition of the insertion handle for suprapatellar would not 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.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: INSERTION HANDLE FOR SUPRAPATELLAR
• Common Device Name: NAIL, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES SELZACH; bohackerweg 5; selzach ; SZ
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 15828844
• Report Number: 8030965-2022-10052
• Device Sequence Number: 6108993
• Product Code: JDS
• UDI-Device Identifier: 10886982068828
• UDI-Public: (01)10886982068828
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K111667
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 03.010.440
• Device Catalogue Number: 03.010.440
• Device Lot Number: 170326-101
• 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: 10/28/2022
• Supplement Date Received by Manufacturer: 04/05/2023; 05/04/2023
• Initial Report FDA Received Date: 11/18/2022
• Supplement Report FDA Received Date: 04/25/2023; 05/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/28/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BALL HEX SCREWDRIVER 8MM; CANN CONNECTING SCR F/PERCUTAN INSTS NL
• Patient Age: 68 YR
• Patient Sex: Unknown