MAUDE Adverse Event Report: SYNTHES GMBH 3.5/4.5MM VA PPFX PROX FEMUR HOOK PL/SMALL/5HOLES/LEFT; PLATE, FIXATION, BONE

Model Number	02.221.085
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/16/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2022, while inserting a 3.5 va locking screw into a va periprosthetic hook plate, the 3.5 va locking screw did not engage the plate.The surgeon decided to leave the hole empty and place another screw in a different hole.Additionally, the surgeon only chose to put one 3.5 va locking screw in the head of the plate along with 2 cables instead of the 2 recommended.The surgeon also stated that the 3.2mm drill bit was dull.He was pleased with the fixation and the surgery was successfully completed.There was 5 mins of surgical delay.There was no adverse consequence to the patient.No further information is available.This report involves one 3.5/4.5mm va ppfx prox femur hook pl/small/5holes/left.This is report 2 of 3 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.Additional narrative: 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: 3.5/4.5MM VA PPFX PROX FEMUR HOOK PL/SMALL/5HOLES/LEFT
• 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: 15537697
• Report Number: 8030965-2022-07819
• Device Sequence Number: 5930326
• Product Code: HRS
• UDI-Device Identifier: 10886982275622
• UDI-Public: 10886982275622
• 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
• Device Implanted Year: 2022
• 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: 02.221.085
• Device Catalogue Number: 02.221.085
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/16/2022
• Initial Report FDA Received Date: 10/04/2022
• 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: VA LOCKSCR Ø3.5 SELF-TAP L14 SST
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 97 KG