MAUDE Adverse Event Report: SYNTHES GMBH COMPRES/DISTRACTION INSTR; PLATE, FIXATION, BONE

Catalog Number	03.111.907
Medical Device Problem Codes	Device-Device Incompatibility (2919); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).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 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 (b)(6) 2025 during the procedure, while following the surgical technique of inserting the 2.0mm wires into the compression/distraction instrument, the surgeon experienced extreme difficulty inserting the wires.The wires were new, unused, and were not bent.In addition, the surgeon experienced extreme difficulty turning the spindle on the compression/distraction device.Upon further inspection of the instrument, it seems that the instrument is slightly bent, creating an imbalance in both the wire holes along with the spindle mechanism.The procedure was successfully completed with no surgical delays, no patient consequences and no other medical intervention required.
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.The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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.H11 additional narrative: h3, h6: service and repair evaluation: the customer reported that on (b)(6) 2025 during the procedure, while following the surgical technique of inserting the 2.0mm wires into the compression/distraction instrument, the surgeon experienced extreme difficulty inserting the wires.The wires were new, unused, and were not bent.In addition, the surgeon experienced extreme difficulty turning the spindle on the compression/distraction device.Upon further inspection of the instrument, it seems that the instrument is slightly bent, creating an imbalance in both the wire holes along with the spindle mechanism.The repair technician reported that bent prong and spindle is hard to torn.The item is not repairable per the inspection sheet.The cause of the issue is faulty parts.The item will be forwarded to customer quality.The evaluation was confirmed.Device history review: part:03.111.907, lot:l557320, manufacturing site: werk balsthal, supplier: na, release to warehouse date: 26 sep 2017, expiration date: na.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: COMPRES/DISTRACTION INSTR
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; luzernstrasse 19-21; zuchwil 4528 ; SZ 4528
• Manufacturer (Section G): WERK BALSTHAL (CH); dornacherstrasse 20; balsthal 4710 ; SZ 4710
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 21228239
• Report Number: 8030965-2025-00823
• Device Sequence Number: 20701881
• Product Code: HRS
• UDI-Device Identifier: 10886982072658
• UDI-Public: (01)10886982072658(10)L557320
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,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: 03.111.907
• Device Lot Number: L557320
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/03/2025
• Supplement Date Received by Manufacturer: 02/05/2025; 02/11/2025
• Initial Report FDA Received Date: 01/24/2025
• Supplement Report FDA Received Date: 02/10/2025; 02/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/26/2017
• 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