MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC DHS/DCS LAG SCREW 12.7MM THREAD/95MM; APPLIANCE,FIXATION,NAIL

Model Number	280.950
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional product code jdo.Initial reporter phone number: (b)(6).(b)(4).The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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 or Problem 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) dhs®/dcs® lag screw 12.7mm thread/95mm.This is report 2 of 4 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.H3, h4, h6: part 280.950, lot 6054755: manufacturing site: elmira.Release to warehouse date: january 21, 2009.This raw material lot met all dimensional and visual criteria at the time of manufacture with no issues documented during the manufacture that would contribute to this complaint condition.H3, h6: a product investigation was completed: upon visual inspection, it is observed that there were few scratches all over the body.Threads of the received device was slightly deformed.The relevant drawings were reviewed during the investigation; no design issues or discrepancies were noted during the investigation.Dimensional inspection of the device was performed, and it was measured to be within specification.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: DHS/DCS LAG SCREW 12.7MM THREAD/95MM
• Common Device Name: APPLIANCE,FIXATION,NAIL
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10629380
• Report Number: 2939274-2020-04489
• Device Sequence Number: 19634611
• Product Code: KTT
• UDI-Device Identifier: 10886982176332
• UDI-Public: (01)10886982176332
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K791619
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/13/2020

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?: No
• Operator of Device: Health Professional
• Device Model Number: 280.950
• Device Catalogue Number: 280.95
• Device Lot Number: 6054755
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2020
• Initial Date Received by Manufacturer: 09/13/2020
• Supplement Date Received by Manufacturer: 10/21/2020
• Initial Report FDA Received Date: 10/05/2020
• Supplement Report FDA Received Date: 11/02/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention