MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 1.7MM CABLE WITH CRIMP 750MM-STERILE; CERCLAGE FIXATION

Model Number 298.801.01S

Device Problems Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)

Patient Problems Bone Fracture(s) (1870); Failure of Implant (1924); No Code Available (3191)

Event Date 01/01/2019

Event Type  Injury  

Manufacturer Narrative

Date of event: unknown date in 2019.Initial reporter is synthes employee.The investigation could not be completed; no conclusion could be drawn, as no product was received.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.

Event Description

It was reported on (b)(6) 2019, abnormal radiographic evaluation occurred.There was a hardware failure at the fracture site, as well as angulation of the fracture.One (1) cerclage cable with crimp, four (4) threaded cerclage positioning pin-sterile, three (3) cable with crimp and one (1) titanium cerclage positioning pin-sterile were implanted on (b)(6) 2019.The original indication for using the synthes devices was for treatment of an intraoperative femur fracture.It was unknown if there was a surgical delay.Procedure outcome and patient status are unknown.This report is for one (1) 1.7mm cable with crimp 750mm-sterile.This is report 5 of 7 for (b)(4).

Event Description

This is report 5 of 9 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.Complainant part is not expected to be returned for manufacturer review/investigation.Manufacturing location: supplier rti surgical / inspected, packaged and released by: monument; manufacturing date: february 15, 2018; expiration date: november 30, 2022; part: 298.801.01s, 1.7mm cable with crimp 750mm -sterile; lot: p298568; lot quantity: 240.Purchased finished goods traveler met all inspection acceptance criteria.Certificate of conformance supplied by rti surgical was reviewed and determined to be conforming.Sterilization results noted on certificate met defined requirements.Inspection sheet, incoming final inspection met all inspection acceptance criteria.Packaging and labeling were 100% inspected and met all inspection acceptance criteria.This lot met all dimensional, visual, sterility and packaging criteria at the time of release with no issues documented during the inspection or release of the product that would contribute to this complaint condition.Product was not returned.Based on the information available, it has been determined that no corrective and 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.Code 3191 used to capture required surgical intervention.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: 1.7MM CABLE WITH CRIMP 750MM-STERILE
• Type of Device: CERCLAGE FIXATION
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8620498
• MDR Text Key: 145396889
• Report Number: 2939274-2019-58141
• Device Sequence Number: 1
• Product Code: JDQ
• UDI-Device Identifier: 10886982182500
• UDI-Public: (01)10886982182500
• Combination Product (y/n): N
• PMA/PMN Number: K992616
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 04/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2022
• Device Model Number: 298.801.01S
• Device Catalogue Number: 298.801.01S
• Device Lot Number: P298568
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/05/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR
• Patient Weight: 118