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

Model Number	04.038.100
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Reaction (2414); No Code Available (3191)
Date of Event	01/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/ investigation.(b)(4).The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.Device history lot: part number: 04.038.100, lot number: 7938533, part manufacture date: feb 25, 2015, manufacturing location: (b)(4), part expiration date: n/a, 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 screw 100mm 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.A review of the raw material device history record revealed this lot met all specifications with no nonconformance noted.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 review: 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.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 the patient underwent removal of the tfna screw on (b)(6) 2020, the tfna screw was protruding out from the hip, the screw prominence, she wants it to be fix or removed.The surgery was successfully completed.The patient outcome was unknown.Concomitant device reported: unk - nail: tfna (part # unknown; lot # unknown; quantity: 1), unk- tfna helical blade: (part # unknown, lot # unknown, quantity: unknown).This complaint involves one (1) device.This report is for (1) tfna screw 100mm.This is report 1 of 1 for (b)(4).

• Brand Name: TFNA SCREW 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: 10649941
• Report Number: 2939274-2020-04582
• Device Sequence Number: 14139042
• Product Code: HSB
• UDI-Device Identifier: 10886982098504
• UDI-Public: (01)10886982098504
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: K131548
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/18/2020

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: 04.038.100
• Device Catalogue Number: 04.038.100
• Device Lot Number: 7938533
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/18/2020
• Initial Report FDA Received Date: 10/08/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 82 YR
• Patient Weight: 49