MAUDE Adverse Event Report: SYNTHES GMBH 1.6MM COMPRESSION WIRE 15MM THREAD/150MM LENGTH; INSTRUMENT, COMPRESSION

Model Number	03.211.415
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/16/2023
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.Additional narrative: complainant part is not expected to be returned for manufacturer review/investigation.Initial reporter facility name: nippon telegraph and telephone east corporation ntt east sapporo hospital 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
Device report from synthes reports an event in japan as follows: it was reported that the patient underwent open reduction/internal fixation for a clavicular diaphyseal fracture with the compression wire in question on (b)(6) 2023.In the surgery, the compression wire used for temporary fixation was broken at the top of the ball tip.It was confirmed that the tip of the wire did not remain inside the body.According to the surgeon, it may have been broken due to excessive tension due to the wrong axial direction during insertion.The surgery was completed successfully within a 30-minute delay.No other medical intervention was required, and the patient status was reported to be stable.This report involves one 1.6mm compression wire 15mm thread/150mm length.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.Part # 03.211.415.01s.Lot # 9l99642.Manufacturing site: werk selzach.Release to warehouse date: 24 oct 2022.Expiration date: 01 oct 2032.Supplier: (b)(4).A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.Part #: 03.211.415.01.Lot #: 1644p54.Manufacturing site: balsthal.Release to warehouse date: 13-oct-2022.A manufacturing record evaluation was performed for the finished device lot #, 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.

• Brand Name: 1.6MM COMPRESSION WIRE 15MM THREAD/150MM LENGTH
• Common Device Name: INSTRUMENT, COMPRESSION
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK SELZACH; bohackerweg 5; selzach CO 2545 ; SZ 2545
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 16691531
• Report Number: 8030965-2023-04141
• Device Sequence Number: 20313719
• Product Code: HWN
• UDI-Device Identifier: 10886982076304
• UDI-Public: (01)10886982076304
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• 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: 03.211.415
• Device Catalogue Number: 03.211.415.01S
• Device Lot Number: 9L99642
• 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: 03/16/2023
• Supplement Date Received by Manufacturer: 04/07/2023
• Initial Report FDA Received Date: 04/06/2023
• Supplement Report FDA Received Date: 04/25/2023
• 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