MAUDE Adverse Event Report: SYNTHES GMBH LCP WRIST FUSION SHORT BEND PLATE; PLATE, FIXATION, BONE

Model Number	02.110.151
Medical Device Problem Codes	Defective Device (2588); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/20/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the surgeon commented that the wrist fusion plate, it did not fit the anatomy well.The surgeon attempted to bring the plate to the bone, but the screws pulled out of bone trying to bring the plate down.The surgeon ultimately accepted the plate slightly off the bone.The surgeon did not trim the dorsal aspect of the distal radius down.The surgery was successfully completed with 10min of surgical delay.No fragments were generated.No patient consequence was reported.Concomitant device reported: unk - screws: trauma (part# unknown; lot# unknown; quantity: unknown).This report is for one (1) lcp wrist fusion short bend plate this is report 1 of 3 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.Complainant part is not expected to be returned for manufacturer review/investigation.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.

• Brand Name: LCP WRIST FUSION SHORT BEND PLATE
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): ELMIRA; 35 airport road; horseheads NY 14845
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 15771016
• Report Number: 8030965-2022-09590
• Device Sequence Number: 20479006
• Product Code: HRS
• UDI-Device Identifier: 10886982030412
• UDI-Public: (01)10886982030412
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K042355
• 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: Physician
• 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: 02.110.151
• Device Catalogue Number: 02.110.151
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/20/2022
• Initial Report FDA Received Date: 11/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - SCREWS: TRAUMA
• Patient Age: 74 YR
• Patient Sex: Female
• Patient Weight: 73 KG