MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 4.5MM THREADED CERCLAGE POSITIONING PIN-STERILE; CERCLAGE FIXATION

Model Number	298.803S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure of Implant (1924); Impaired Healing (2378); No Code Available (3191)
Date of Event	01/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event is an unknown date in 2019.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Reporter is a 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.(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) 2019, an 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.Procedure outcome and patient status are unknown.This report is for a 4.5mm threaded cerclage positioning pin-sterile.This is report 8 of 9 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.Device history lot manufacturing location: brandywine / packaged, sterilized and released by: monument part number: 298.803s, 4.5mm threaded cerclage positioning pin-sterile lot number: h519278 (sterile) release to warehouse date: 05-jan-2018.Expiration date: 30-nov-2026.This lot met all dimensional, visual, sterility and packaging criteria at the time of release with no issues documented during the manufacture of the product that would contribute to this complaint condition.Component part(s) reviewed: part number: 298.803y, 4.5 threaded cerclage positioning pin.Lot number: h473346 (non-sterile).Brandywine work order traveler met all inspection acceptance criteria.Inspection sheet, ns044768 rev c met all inspection acceptance criteria.Part number:11014, 316l**ri8.00.Lot number: 9970333.This lot met all dimensional, visual, sterility and packaging criteria at the time of release 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: 4.5MM THREADED CERCLAGE POSITIONING PIN-STERILE
• Common Device Name: CERCLAGE FIXATION
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8674792
• Report Number: 2939274-2019-58498
• Device Sequence Number: 19422986
• Product Code: JDQ
• UDI-Device Identifier: 10886982182531
• UDI-Public: (01)10886982182531
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K992891
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/18/2019

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 Model Number: 298.803S
• Device Catalogue Number: 298.803S
• Device Lot Number: H519278
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/18/2019
• Supplement Date Received by Manufacturer: 06/06/2019
• Initial Report FDA Received Date: 06/06/2019
• Supplement Report FDA Received Date: 06/14/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR
• Patient Weight: 118