MAUDE Adverse Event Report: SYNTHES GMBH 3.5/4.5 VA PROX FEMUR HOOK PL/LRG/217/RT; PLATE, FIXATION, BONE

Catalog Number	02.221.086
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/11/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6), 2023 during a surgery, the surgical tech said the pistol grip cable tensioner was very complicated.The surgeon used it successfully, and the cables were successfully placed.There were no allegations against the functioning of the device.Additionally the surgeon said a proximal femur hook plate was too bulky for the patient and decided to use a different option.There was no issues with the plate itself, it was just how it fit the patients anatomy.The surgery was successfully completed.Patient status/ outcome: stable.Concomitant device reported: unk - cable/wire (part# unknown; lot# unknown; quantity: unknown).This report is for one (1) 3.5/4.5 va prox femur hook pl/lrg/217/rt.This is report 1 of 1 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.D9: complainant part is not expected to be returned for manufacturer review/investigation.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.

• Brand Name: 3.5/4.5 VA PROX FEMUR HOOK PL/LRG/217/RT
• Common Device Name: PLATE, FIXATION, BONE
• 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: 17818184
• Report Number: 8030965-2023-12129
• Device Sequence Number: 19418841
• Product Code: HRS
• UDI-Device Identifier: 10886982275578
• UDI-Public: (01)10886982275578
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K210205
• 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 Catalogue Number: 02.221.086
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/11/2023
• Initial Report FDA Received Date: 09/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CABLE TENSIONER WITH PISTOL GRIP.; UNK - CABLE/WIRE.
• Patient Age: 66 YR
• Patient Sex: Female