MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC BOLT FOR FEMORAL NECK SYSTEM 85MM LENGTH-STERILE; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Model Number 04.168.290S

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

Patient Problems Pain (1994); No Code Available (3191); Physical Asymmetry (4573)

Event Date 01/01/2020

Event Type  Injury  

Manufacturer Narrative

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.(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 a revision procedure due to loss of reduction of the femoral neck system (fns).Before the revision procedure, the patient experienced pain.Initially, the patient was implanted with the reported device on (b)(6) 2020.During the revision procedure, the distal locking screw had to be drilled out as it was cross threaded with the fns plate.All the fns devices were successfully removed then the patient was revised to a total hip arthroplasty.The procedure was successfully completed with 20-minute surgical delay.Patient status is unknown.(b)(4) will capture the post-op event where the patient underwent a revision procedure due to loss of reduction of the femoral neck system (fns), while (b)(4) will capture the intra-op event of the revision procedure where the distal locking screw had to be drilled out as it was cross threaded into the fns plate.This report is for one (1) bolt for femoral neck system 85mm length-sterile this is report 2 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.Part 04.168.285s, lot 46p2080: manufacturing site: grenchen.Release to warehouse date: march 26, 2020.A manufacturing record evaluation was performed for the non-sterile device, and no non-conformances were identified.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: BOLT FOR FEMORAL NECK SYSTEM 85MM LENGTH-STERILE
• Type of Device: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10876171
• MDR Text Key: 217368960
• Report Number: 2939274-2020-05247
• Device Sequence Number: 1
• Product Code: KTT
• UDI-Device Identifier: 10886982274748
• UDI-Public: (01)10886982274748
• Combination Product (y/n): N
• PMA/PMN Number: K172872
• 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: 10/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 04.168.290S
• Device Catalogue Number: 04.168.285S
• Device Lot Number: 46P2080
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/03/2020
• Patient Sequence Number: 1
• Treatment: 5.0MM TI LK SCR SLF-TPNG T25 STARDR REC 36MM; ANTIROT SCRW FEM NECK SYS 85MM S; FEMORAL NECK SYSTEM PLATE 1 HOLE - STERILE; 5.0MM TI LK SCR SLF-TPNG T25 STARDR REC 36MM; ANTIROT SCRW FEM NECK SYS 85MM S; FEMORAL NECK SYSTEM PLATE 1 HOLE - STERILE
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR
• Patient Weight: 56