MAUDE Adverse Event Report: SYNTHES GMBH LARGE EX-FIX COMBINATION CLAMP MR-CONDITIONAL; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Model Number	390.005
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2022
Type of Reportable Event	Malfunction
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.Only the event year is known.Additional device product codes: lxt.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Reporter is a j&j employee.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.
Event or Problem Description
It was reported that on an unknown date, 11 total bar to bar and pin to bar clamps cold welded.The surgeon spent an extra 30 minutes during the case on bilateral ex-fixes.No further information is available.This report involves one large ex-fix combination clamp mr-conditional.This is report 8 of 11 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.H3, h4, h6: part 390.005-us, lot 2238p36: part manufacture date: september 20, 2022.Manufacturing location: brandywine.A review of the device history record of this lot revealed no complaint-related anomalies.The device history record shows the device assembly was processed through all operations on the released and had met all specification criteria at the time of release with no issues documented that would contribute to the complaint condition.H3, h6: a photo investigation was completed: visual analysis of the photo revealed that the device had no signs of defect.Functional test cannot be performed through photo evidence.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.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: LARGE EX-FIX COMBINATION CLAMP MR-CONDITIONAL
• 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): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 15968338
• Report Number: 8030965-2022-10973
• Device Sequence Number: 5668057
• Product Code: KTT
• UDI-Device Identifier: 10886982197825
• UDI-Public: 10886982197825
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K161417
• 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

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
• Device Model Number: 390.005
• Device Catalogue Number: 390.005
• Device Lot Number: 2238P36
• 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: 11/14/2022
• Supplement Date Received by Manufacturer: 12/20/2022
• Initial Report FDA Received Date: 12/13/2022
• Supplement Report FDA Received Date: 12/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/20/2022
• 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: LRG EX-FIX COMBINATION CLAMP MR-COND; LRG EX-FIX COMBINATION CLAMP MR-COND; LRG EX-FIX COMBINATION CLAMP MR-COND; LRG EX-FIX COMBINATION CLAMP MR-COND; UNK - EX-FIX CLAMPS: LARGE; UNK - EX-FIX CLAMPS: LARGE; UNK - EX-FIX CLAMPS: LARGE; UNK - EX-FIX CLAMPS: LARGE; UNK - EX-FIX CLAMPS: LARGE; UNK - EX-FIX CLAMPS: LARGE
• Patient Sex: Unknown