MAUDE Adverse Event Report: SYNTHES GMBH COMP/DISTRACTION INSTR FOR ULNA OSTEO; SCREW, FIXATION, BONE

Model Number	03.111.907
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/06/2022
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.Additional product code: hrs.Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.Reporter is a j&j sales representative.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
Device report from synthes reports an event in canada as follows: it was reported on (b)(6) 2022, that 2.0mm drill tip wire became stuck in cannulation of compression/distraction device.Surgeon was able to remove the wire with pliers but cannulation was unusable.Case continued with only using wires in 3 remaining holes of compression/distraction device.On inspection after the case the wires in the set all looked heavily used and blunt/bent so were discarded.Ulna shortening osteotomy.Surgery was delayed for 5 minutes and more.Procedure was successfully completed.No fragments were generated.Patient status/ outcome / consequences: no.This report is for one (1) comp/distraction instr for ulna osteo.This is report 1 of 11 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.H10 additional narrative: a manufacturing record evaluation was performed for the finished device 03.111.907-us lot #589p061, and no non-conformances were identified.Part #: 03.111.907-us lot #: 589p061 manufacturing site: balsthal release to warehouse date: 10.Mar 2022 the photo was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device from the attachment.Visual analysis of the photo revealed that comp/distraction instr for ulna osteo was observed with scratches in one cannulation.The complaint condition could not be confirmed as the photo does not show functionality of the device.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 comp/distraction instr for ulna osteo.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.If information is obtained that was not available for this medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: COMP/DISTRACTION INSTR FOR ULNA OSTEO
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK BALSTHAL (CH); dornacherstrasse 20; balsthal ; SZ
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 15491304
• Report Number: 8030965-2022-07381
• Device Sequence Number: 1945801
• Product Code: HWC
• UDI-Device Identifier: 10886982072658
• UDI-Public: (01)10886982072658
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K113364
• 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,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 Model Number: 03.111.907
• Device Catalogue Number: 03.111.907
• Device Lot Number: 589P061
• 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: 09/07/2022
• Supplement Date Received by Manufacturer: 09/28/2022
• Initial Report FDA Received Date: 09/27/2022
• Supplement Report FDA Received Date: 10/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Sex: Unknown