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

Catalog Number	390.008
Medical Device Problem Code	Device Slipped (1584)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional narrative: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Reporter is a synthes 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.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 prior to a procedure on (b)(6) 2022, the clip on the self-holding mechanism of the clamp did not work properly; it was loose.There was no patient consequence.This report is for a large ex-fix open adj clamp mr-conditional.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.H6: part # 390.008, lot # 57p2720, manufacturing site: selzach, release to warehouse date: june 2, 2020, supplier: (b)(4).A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.Visual inspection: the clamp can be mounted self-hold (p/n: 390.008, lot number: 57p2720) was received at juarez pal.Visual examination of the returned device did not find anything indicative of a product defect.Functional test the returned clamp was tightened and loosened without difficulty.No evidence of looseness was observed after the clamp was tightened.The complaint condition was not replicated.Device failure/defect identified? no.Dimensional inspection: a dimensional inspection was not conducted as the complaint condition was not replicated.Document/specification review: based on the date of manufacture, the current and manufactured revision of drawings were reviewed.No design issues or discrepancies were identified.Complaint confirmed? no.Investigation conclusion: the overall complaint was not confirmed for the received device.No definitive root cause could be determined based on the provided information.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.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 OPEN ADJ 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): SYNTHES SELZACH; bohackerweg 5; selzach 2545 ; SZ 2545
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 13509428
• Report Number: 8030965-2022-00829
• Device Sequence Number: 5148473
• Product Code: KTT
• UDI-Device Identifier: 07611819760592
• UDI-Public: (01)07611819760592
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: K122455
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,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
• Operator of Device: Health Professional
• Device Catalogue Number: 390.008
• Device Lot Number: 57P2720
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/12/2022
• Supplement Date Received by Manufacturer: 02/15/2022
• Initial Report FDA Received Date: 02/10/2022
• Supplement Report FDA Received Date: 03/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/02/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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
• Patient Sex: Unknown