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

Model Number 04.038.090S

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.(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.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 Description

It was reported that on an unknown date, the patient underwent a revision of a proximal femoral nailing system (tfna) due to nonunion.It was revised to femoral recon nail (frn).Date of original implant was on (b)(6) 2018.Procedure was completed successfully.Patient status was stable.This is report 2 of 3 for (b)(4).

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.H10 additional narrative: h4 device history.Part number: 04.038.090s.Lot number: h598447.Part manufacturing date: 20 april 2018.Manufacturing site: elmira.Part expiration date: 31 march 2028.Nonconformance noted: n/a.A review of the device history record revealed no complaint related anomalies.The device history record shows lot h598447 of tfna screws was processed through the normal manufacturing and inspection operations with no rework or nonconformances noted.This 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.A review of the raw material device history record(s) determined the raw material lot h463275 met all specifications with no issues documented that would contribute to this complaint condition.H11 corrected data; b5.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 Description

Updated event.Revision surgery occurred on (b)(6) 2019.

• Brand Name: TFNA SCREW 90MM - STERILE
• Type of Device: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9497565
• MDR Text Key: 185720962
• Report Number: 2939274-2019-62725
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 10886982098474
• UDI-Public: (01)10886982098474
• Combination Product (y/n): N
• PMA/PMN Number: K131548
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 12/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 04.038.090S
• Device Catalogue Number: 04.038.090S
• Device Lot Number: H598447
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/23/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 20 YR
• Patient Weight: 61