MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TFNA SCREW 85MM - STERILE; ROD,FIXATION,INTRAMEDULLARY

Model Number	04.038.085S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product was not returned.Based on the information available, it has been determined that no corrective and preventative action is proposed.Device history lot: device history review done by (b)(4) on 26 feb 2020.Part number: 04.038.185s, lot number: h577485, part manufacture date: apr 13, 2018, manufacturing location: (b)(4), part expiration date: mar 31, 2028, nonconformance noted: n/a.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 screw was processed through the normal manufacturing and inspection operations with no non-conformances or rework noted.The lot quantity of (b)(4) pieces 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.A review of the device history record for the raw material revealed no complaint related anomalies.The device history record shows this lot met all requirements at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.Device history review: the lot quantity of (b)(4) pieces 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.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 on an unknown date that the patient underwent removal of a short trochanteric femoral nail (tfna) on (b)(6) 2020.The patient sustained a distal third femur fracture.All implants were successfully explanted without issue and the patient was revised with a (b)(6) nail.No patient consequences reported.This complaint involves four (4) devices.This is 2 of 4 for report (b)(4).

• Brand Name: TFNA SCREW 85MM - 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: 9824654
• Report Number: 2939274-2020-01247
• Device Sequence Number: 14220135
• Product Code: HSB
• UDI-Device Identifier: 10886982098450
• UDI-Public: (01)10886982098450
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K131548
• 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
• Report Date (Section B): 02/15/2020

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: 04.038.085S
• Device Catalogue Number: 04.038.085S
• Device Lot Number: H577485
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/15/2020
• Initial Report FDA Received Date: 03/12/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 85 YR
• Patient Weight: 56