MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TFNA SCREW 90MM - STERILE; ROD,FIXATION,INTRAMEDULLARY

Model Number	04.038.090S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Implant date is unknown.It occurred 2 years ago at another facility.Complainant part is not expected to be returned for manufacturer review/investigation.A device history record review: part number: 04.038.090s lot number: 9837605 date of manufacture: 22 july 2015 place of manufacture: elmira part expiration date: 30 june 2025 nonconformance noted: n/a 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 90mm 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 with no non-conformance 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.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.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 a patient underwent removal of one trochanteric fixation nail - advanced (tfna) nail, one (1) tfna lag screw and one (1) tfna distal locking screw on (b)(6) 2018 due to an infection.The tfna construct was initially implanted about two (2) years back to treat an unknown trochanteric fracture.The fracture was reported to have healed since; however, the patient developed an infection at an unknown time.Thus, the surgeon decided to remove the tfna construct and treat the infection using an unknown antibiotic cement.The removal of the tfna construct was conducted successfully, with no complications to the patient, except however, the packaging on the sterile reaming rods shearing off on one side while opening two (2) of these reaming rods during the removal surgery.This did not delay the surgery since other sets were available at the time for use.Multiple x-rays were taken during the surgery, however, not due to the reaming rods' packaging shearing off.The patient was reported to be stable.This is report 1 of 3 for (b)(4).
Additional Manufacturer Narrative
Device was used for treatment, not diagnosis.Device is a single use device but was not reprocessed or reused.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: TFNA SCREW 90MM - 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: 7286193
• Report Number: 2939274-2018-50690
• Device Sequence Number: 1475989
• Product Code: HSB
• UDI-Device Identifier: 10886982098474
• UDI-Public: (01)10886982098474(17)250630(10)9837605
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K131548
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/25/2018

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2025
• Device Model Number: 04.038.090S
• Device Catalogue Number: 04.038.090S
• Device Lot Number: 9837605
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/25/2018
• Supplement Date Received by Manufacturer: 04/13/2018
• Initial Report FDA Received Date: 02/21/2018
• Supplement Report FDA Received Date: 04/30/2018
• 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