MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 11MM/130 DEG TI CANN TFNA 400MM/LEFT - STERILE; ROD,FIXATION,INTRAMEDULLARY

Model Number 04.037.161S

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

Patient Problem Arthritis (1723)

Event Type  Injury  

Manufacturer Narrative

The investigation could not be completed, no product was received; 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 Description

It was reported that on (b)(6) 2020, the patient underwent removal of a proximal femoral nailing system (tfna) to convert to a total hip arthroplasty due to post-traumatic arthritis.The patient's status is unknown.This complaint involves three (3) devices.This is report 2 of 3 for (b)(4).

Manufacturer Narrative

Product complaint # (b)(4).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, h6: investigation summary: the complaint condition of an post-traumatic arthritis could be confirmed, but there is no product problem reported.Product was not returned.Based on the information available, it has been determined that no corrective and preventive 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.H3, h4, h6: a review of the device history record.Device history lot manufacturing location: monument, manufacturing date: 14-dec-2017, expiration date: 30-nov-2027, part number: 04.037.161s, 11mm/130 deg ti cann tfna 400mm / left ¿ sterile, lot number: h523658 (sterile) , lot quantity: 5.One piece was scrapped in cell at op #50, mill flutes and relief, due to a raw material cosmetic defect.Work order traveler met all inspection acceptance criteria apart from the one piece noted.Inspection sheet, in process / inspect dimensional / final, met all inspection acceptance criteria apart from the one piece noted.Inspection sheet, tfna assembly inspection, met all inspection acceptance criteria.Packaging label log lppf, lmd/lpf rev d was reviewed and determined to be conforming.Packaging bom was reviewed and determined to be conforming with no deviations to normal packaging identified.Scn 14464 supplied by ees (albuquerque) was reviewed and determined to be conforming.This lot met all dimensional, visual, sterility and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.Component part(s) reviewed: component parts were not reviewed as the reported complaint condition of ¿removed due to post-traumatic arthritis¿ does not indicate breakage of the nail or any of its components.Therefore, review of the raw materials would not be pertinent to the reported complaint condition.Device history batch null, device history review 19-mar-2020: dhr reviewed.This lot met all dimensional, visual, sterility and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.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: 11MM/130 DEG TI CANN TFNA 400MM/LEFT - STERILE
• Type of Device: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9929423
• MDR Text Key: 186840562
• Report Number: 2939274-2020-01730
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 10886982096692
• UDI-Public: (01)10886982096692
• Combination Product (y/n): N
• PMA/PMN Number: K160167
• 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: 03/10/2020

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
• Device Operator: Health Professional
• Device Model Number: 04.037.161S
• Device Catalogue Number: 04.037.161S
• Device Lot Number: H523658
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/10/2020
• Initial Date FDA Received: 04/06/2020
• Supplement Dates Manufacturer Received: 04/09/2020
• Supplement Dates FDA Received: 04/28/2020
• Patient Sequence Number: 1
• Treatment: 11MM/130 DEG TI CANN TFNA 400MM/LEFT - STERILE; TFNA FENESTRATED HELICAL BLADE 100MM; UNK - SCREWS: LOCKING
• Patient Outcome(s): Required Intervention
• Patient Age: 35 YR
• Patient Weight: 106