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

Model Number	04.038.400S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Arthritis (1723); Necrosis (1971); Pain (1994); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional pro-code: ktt.Complainant part is not expected to be returned for manufacturer review/investigation.A review of the device history record.Device history lot: part number: 04.038.400s, lot number: h375403, part manufacturing date: 12 july 2017, manufacturing site: (b)(4), part expiration date: 31 may 2027, nonconformance noted: n/a.A review of the device history record revealed no complaint related anomalies.The device history record shows lot h375403 of tfna fenestrated helical blades was processed through the normal manufacturing and inspection operations with no rework or non conformances noted.This 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.A review of the raw material device history record(s) determined the raw material lot h123928 met all specifications with no issues documented that would contribute to this complaint condition.Device history batch null, device history review a review of the device history record revealed no complaint related anomalies.This 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.Investigation summary 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.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) 2019, the patient underwent a hardware removal and total hip arthroplasty due to an advanced left hip osteoarthritis with retained hardware from a previous fracture and signs of avascular necrosis with early collapse of the femoral head.Originally, the patient was implanted with the trochanteric femoral nailing system advanced (tfna) due to non-displaced left hip intertrochanteric femur fracture in (b)(6) 2018.However, six (6) months after the implant surgery, the patient failed conservative measures, including anti-inflammatories and pain medications.Moreover, the patient also had an intra-articular injection without relief of his pain and then was admitted to the hospital to have the hardware removed and converted to a total hip arthroplasty.The surgeon noted that the locking mechanism and hole for the helical blade in the tfna nail was bent and deformed and an inspection showed a large notch anteriorly.The surgery was completed with no adverse consequence to the patient.Concomitant devices reported: reaming rod (part# 351.706s, lot# h564327, quantity# 1).This complaint involves three (3) devices.This report is 2 of 3 for (b)(4).

• Brand Name: TFNA FENESTRATED HELICAL BLADE 100MM - STERILE
• 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: 9032953
• Report Number: 2939274-2019-60530
• Device Sequence Number: 13899382
• Product Code: HSB
• UDI-Device Identifier: 10886982099297
• UDI-Public: (01)10886982099297
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K160167
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/14/2019

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: 04.038.400S
• Device Catalogue Number: 04.038.400S
• Device Lot Number: H375403
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/14/2019
• Initial Report FDA Received Date: 09/13/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 88 YR
• Patient Weight: 103