MAUDE Adverse Event Report: SYNTHES GMBH WASHER 13.0MM; WASHER, BOLT NUT

Model Number	419.99
Medical Device Problem Code	Device Slipped (1584)
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032); Distress (2329); Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	08/01/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent percutaneous pinning of the right hip on (b)(6) 2021 to treat intertrochanteric fracture.The patient suffered severe pain and lack of mobility; her hip was unable to heal properly, and she has permanent damage in her hip which has caused emotional distress.On or about august 2021, the patient underwent surgery to remove the screws which had become loose and hindered healing of the hip.This report is for one (1) washer 13.0mm.This is report 5 of 5 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.Additional narrative: device available for evaluation: complainant part is not expected to be returned for manufacturer review/investigation.Initial reporter name and address: reporter is attorney for plaintiff.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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: WASHER 13.0MM
• Common Device Name: WASHER, BOLT NUT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK HÄGENDORF (CH); im bifang 6; haegendorf 4614 ; SZ 4614
• Manufacturer Contact: kate karberg ; 1302 wrights lane east; west chester, PA 19380 ; 8472871282
• MDR Report Key: 16225946
• Report Number: 8030965-2023-00776
• Device Sequence Number: 5400320
• Product Code: HTN
• UDI-Device Identifier: 10886982214836
• UDI-Public: (01)10886982214836
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 419.99
• Device Catalogue Number: 419.99
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/11/2023
• Initial Report FDA Received Date: 01/23/2023
• 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: 2.8 THRD GUIDE WIRE- TROCAR POINT 300; 2.8 THRD GUIDE WIRE- TROCAR POINT 300; 2.8 THRD GUIDE WIRE- TROCAR POINT 300; 6.5 TI CANNULATED SCREW 16 THREAD 75; 6.5 TI CANNULATED SCREW 16 THREAD 80; 6.5 TI CANNULATED SCREW 16 THREAD 85; 6.5 TI CANNULATED SCREW 16 THREAD 85; 6.5 TI CANNULATED SCREW 16 THREAD 95; WASHER 13.0MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 84 YR
• Patient Sex: Female