MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TFNA SCREW 75MM - STERILE; ROD, FIXATION, INTRAMEDULLARY

Model Number	04.038.075S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient id: (b)(6).Complainant part is not expected to be returned for manufacturer review/investigation.The investigation could not be completed; no conclusion could be drawn, as no product was received.A review of the device history records has been requested.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 trochanteric fixation nail advanced (tfna) which includes one (1) nail and two (2) 5mm locking screws on (b)(6) 2018 due to pain at the trochanteric region.The tfna was implanted on (b)(6) 2016.The patient was noted to have healed and the devices were removed intact.The surgery was successfully completed with no delay.There was no patient consequence; the patient outcome was reported as okay/complete.This is report 2 of 3 for (b)(4).
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Dhr review was completed part number: 04.038.075s , lot number: 7958763 , date of manufacture: 07 april 2015 , place of manufacture: elmira , part expiration date: 28 february 2025 , nonconformance noted: ncr#1129094.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 75mm sterile product was processed through the normal manufacturing and inspection operations with no rework,however there was one nonconformity noted for scrapping one part due to a stray chip found in the m5 x 0.5 - 6h left hand extraction thread.This nonconformance would have no effect on the complaint as the m5 extraction thread still would lock on the instrument and permit extraction.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.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.

• Brand Name: TFNA SCREW 75MM - 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: 7569356
• Report Number: 2939274-2018-52409
• Device Sequence Number: 1317882
• Product Code: HSB
• UDI-Device Identifier: 10886982098412
• UDI-Public: (01)10886982098412
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K131548
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• 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): 05/15/2018

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: 02/28/2025
• Device Model Number: 04.038.075S
• Device Catalogue Number: 04.038.075S
• Device Lot Number: 7958763
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/15/2018
• Supplement Date Received by Manufacturer: 06/20/2018
• Initial Report FDA Received Date: 06/05/2018
• Supplement Report FDA Received Date: 07/11/2018
• 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: 21 YR
• Patient Weight: 51