MAUDE Adverse Event Report: SYNTHES GMBH COMP/DISTRACTION HOLDING SLV/3.0 K-WIRE; INSTRUMENT, COMPRESSION

Model Number	03.111.024
Medical Device Problem Codes	Break (1069); Device-Device Incompatibility (2919); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Depuy synthese is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthese has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthese or its employees that the report constitutes an admission that the device, depuy synthese, 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: d9: complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.E3: reporter is a j&j sales representative.H3, h4, h6: without a lot number the device history records review could not be completed.Product was not returned.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 unknown date, during the case, the compression/distractor broke, along with the 3.0mm sleeves used for it.The piece seems to be missing inside the distractor, so there is no ¿ratchet¿ when you spin the distractor.Also, the sleeves seem bent and a 3.0mm wire can't fit through them.The procedure and patient outcome were unknown.This complain involves three (3) devices.This report is for one (1) comp/distraction holding slv/3.0 k-wire this is report 2 of 3 for complaint (b)(4).

• Brand Name: COMP/DISTRACTION HOLDING SLV/3.0 K-WIRE
• Common Device Name: INSTRUMENT, COMPRESSION
• 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: 16891623
• Report Number: 8030965-2023-05908
• Device Sequence Number: 5956454
• Product Code: HWN
• UDI-Device Identifier: 10886982072238
• UDI-Public: (01)10886982072238
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

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: 03.111.024
• Device Catalogue Number: 03.111.024
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/24/2023
• Initial Report FDA Received Date: 05/08/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: COMP/DISTRACTION HOLDING SLV/3.0 K-WIRE; COMPRESSION/DISTRACTION INSTRUMENT
• Patient Sex: Unknown