MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TFNA FENESTRATED HELICAL BLADE 100MM; ROD,FIXATION,INTRAMEDULLARY

Model Number	04.038.400
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Arthritis (1723)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional product code: ktt.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 or Problem 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 1 of 3 for (b)(4).
Additional 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 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.H3, h4, h6: a review of the device history record.Device history lot , part number: 04.038.400, lot number: h4584250, part manufacture date: n/a, manufacturing location: n/a, part expiration date: n/a, nonconformance noted: n/a, dhr record review: a review of the device history record could not be performed as the product was not returned and the lot number provided does not match the part number.The below dhr review was completed on lot number h458425.Part number: 04.038.400s, lot number: h458425, part manufacture date: 18-oct-2017, manufacturing location: elmira, part expiration date: 30-sep-2027.Dhr record review: a review of the device history record revealed no complaint related anomalies.The device history record shows this lot of tfna fenestrated helical blade 100mm - sterile product was processed through the normal manufacturing and inspection operations with no rework nor nonconformities noted.This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.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.Device history batch null, device history review added 24mar2020.

• Brand Name: TFNA FENESTRATED HELICAL BLADE 100MM
• Common Device Name: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9929419
• Report Number: 2939274-2020-01728
• Device Sequence Number: 19537577
• Product Code: HSB
• UDI-Device Identifier: 10886982099280
• UDI-Public: (01)10886982099280
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K160167
• 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): 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
• Operator of Device: Health Professional
• Device Model Number: 04.038.400
• Device Catalogue Number: 04.038.400
• Device Lot Number: H4584250
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/10/2020
• Supplement Date Received by Manufacturer: 04/09/2020
• Initial Report FDA Received Date: 04/06/2020
• Supplement Report FDA Received Date: 04/28/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 11MM/130 DEG TI CANN TFNA 400MM/LEFT - STERILE; TFNA FENESTRATED HELICAL BLADE 100MM; UNK - SCREWS: LOCKING
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 35 YR
• Patient Weight: 106