MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TFNA SCREW 95MM - STERILE; ROD,FIXATION,INTRAMEDULLARY

Model Number	04.038.095S
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Codes	Pain (1994); Nonunion/Delayed-union Bone Fracture (2369)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient date of birth not available for reporting.Date of implant reported only as 2017, exact date is not known.Complainant part is not expected to be returned for manufacturer review/investigation.Initial reporter telephone not available for reporting.The investigation could not be completed; no conclusion could be drawn, as no product was received.Dhr review was completed.Part number: 04.038.095s.Lot number: h332256.Date of manufacture: 19 may 2017.Place of manufacture: (b)(4).Part expiration date: 30 april 2027.Nonconformance noted: nr-0067805.Description of dhr review: a review of the device history record revealed no complaint related anomalies.The device history record shows this lot of tfna screw 95mm 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.A review of the raw material device history record revealed this lot met all specifications but there was a nonconformance noted.This nr was for scrapping 123 lbs of the 395 lb lot of raw material received for a bent bar straightness non-conformance.This nonconformance had no effect on the complaint as the nonconforming bars would not feed into the production machine.The remaining 272 lbs of this raw material lot conformed and was accepted.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 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 patient was implanted with the trochanteric fixation nail advanced (tfna) nail, tfna screw, and 5.0mm locking screw on unknown date in 2017.On unknown date it was revealed the tfna screw had cut through the lateral cortex of the femur as a result of a non-union.The cut through resulted in irritation of soft tissue.Patient was returned to surgery on (b)(6) 2018 where surgeon removed all hardware.Patient was revised to a total hip construct.This report is for one (1) tfna screw 95mm.This is report 2 of 3 for (b)(4).

• Brand Name: TFNA SCREW 95MM - 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: 7480970
• Report Number: 2939274-2018-51976
• Device Sequence Number: 19258597
• Product Code: HSB
• UDI-Device Identifier: 10886982098498
• UDI-Public: (01)10886982098498
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K131548
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 04/11/2018

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 04.038.095S
• Device Catalogue Number: 04.038.095S
• Device Lot Number: H332256
• Initial Date Received by Manufacturer: 04/11/2018
• Initial Report FDA Received Date: 05/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR
• Patient Weight: 61