MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 130 DEG DHS PLATE-STANDARD BARREL 2 HOLES/46MM; APPLIANCE,FIXATION DEVICE, PROXIMAL FEMUR

Model Number 281.021

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Additional product code ktt.Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.Initial reporter phone: (b)(6).The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.(b)(4).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.

Event Description

It was reported that on (b)(6) 2020, the patient underwent hardware removal due to proximal femur fracture loss of reduction with dynamic hip screw system (dhs) + cannulated screw and was revised to total hip.The procedure outcome and patient's status are unknown.This complaint involves three (3) devices.This report is for (1) 130 deg dhs® plate-standard barrel 2 holes/46mm this is report 1 of 4 for (b)(4).

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.H10: additional narrative: d10 h3, h4, h6: part 281.021, lot l940669: manufacturing site: grenchen.Release to warehouse date: july 20, 2018.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.H3, h6: a product investigation was completed: upon visual inspection, it is observed that there were few scratches all over the body.Few minor dents were observed near the screw holes.The relevant drawings were reviewed during the investigation; no design issues or discrepancies were noted during the investigation.The complaint condition was being confirmed.A definitive root cause for the reported problem could not be determined.During the investigation no unidentified product design/manufacturing issues or discrepancies were observed that may have contributed to the complaint condition.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.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: 130 DEG DHS PLATE-STANDARD BARREL 2 HOLES/46MM
• Type of Device: APPLIANCE,FIXATION DEVICE, PROXIMAL FEMUR
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10628936
• MDR Text Key: 209839824
• Report Number: 2939274-2020-04488
• Device Sequence Number: 1
• Product Code: JDO
• UDI-Device Identifier: 10886982176462
• UDI-Public: (01)10886982176462
• Combination Product (y/n): N
• PMA/PMN Number: K791619
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 09/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 281.021
• Device Catalogue Number: 281.021
• Device Lot Number: L940669
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2020
• Date Manufacturer Received: 10/21/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention