MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 10MM/125 DEG TI CANN TFNA 170MM - STERILE; ROD, FIXATION, INTRAMEDULLARY

Model Number	04.037.012S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event is unknown.Date of implantation is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter email address is unknown.The investigation could not be completed; no conclusion could be drawn, as no product was received.A device history records review has been requested.(b)(4).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 on (b)(6) 2018, a patient was taken to surgery because he suffered a fracture of the mid shaft femur distal to a short trochanteric fixation nail advance (tfna).The surgeon removed the short tfna and replaced it with a long tfna.There was no delay in surgery; the surgery was successful and the patient was stable.There is no allegation or malfunction of the short tfna.Concomitant device: tfna helical blade 105 mm (part: 04.038.305, lot: unknown, quantity: 1), trauma locking screws (part: unknown, lot: unknown, quantity: unknown).This report is for a 10 mm/125 deg ti cann tfna 170 mm ¿ sterile.This is report 1 of 1 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.Patient ethnicity is unknown.Expiration date is now known.Unknown part-, lot number combination in our records.Us part.Item: 04.037.012s; research indicates lot number is h168070; manufacturing (mfg) qty: 6; mfg date: august 17, 2016; mfg location: monument; scn: 12864; expiration date: july 31, 2026; product was inspected and passed.Product was packaged per specification.There were no nonconformance reports (ncrs) or reworks generated during the manufacturing of this lot.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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: 10MM/125 DEG TI CANN TFNA 170MM - 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: 7560808
• Report Number: 2939274-2018-52375
• Device Sequence Number: 2195168
• Product Code: HSB
• UDI-Device Identifier: 10886982095701
• UDI-Public: (01)10886982095701
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K160167
• 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): 05/11/2018

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2026
• Device Model Number: 04.037.012S
• Device Catalogue Number: 04.037.012S
• Device Lot Number: H168070
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/11/2018
• Supplement Date Received by Manufacturer: 07/05/2018
• Initial Report FDA Received Date: 06/01/2018
• Supplement Report FDA Received Date: 07/06/2018
• 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: 88 YR
• Patient Weight: 61