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 Codes	Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Failure of Implant (1924); No Code Available (3191)
Date of Event	01/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of evnt: 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 or Problem 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) 4.5mm threaded cerclage positioning pin-sterile.This is report 3 of 7 for (b)(4).
Event or Problem Description
This is report 3 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.Complainant part is not expected to be returned for manufacturer review/investigation.Manufacturing location: brandywine / packaged, sterilized and released by: monument; part: 298.803s, 4.5mm threaded cerclage positioning pin-sterile; lot: h291086 (sterile); lot quantity: 96; release to warehouse date: february 16, 2017; expiration date: january 31, 2026.Work order traveler met all inspection acceptance criteria.Packaging label log lppf was reviewed and determined to be conforming.Packaging bom was reviewed and determined to be conforming with no deviations to normal packaging identified.Sterilization control number (scn) 13453 supplied by sterigenics was reviewed and determined to be conforming.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: 298.803y, 4.5 threaded cerclage positioning pin; lot: h285314 (non-sterile); lot quantity: 96 brandywine work order traveler met all inspection acceptance criteria.Inspection sheet 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: 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: 8620453
• Report Number: 2939274-2019-58138
• Device Sequence Number: 2117825
• 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 Expiration Date: 01/31/2026
• Device Model Number: 298.803S
• Device Catalogue Number: 298.803S
• Device Lot Number: H291086
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/18/2019
• Supplement Date Received by Manufacturer: 06/05/2019
• Initial Report FDA Received Date: 05/17/2019
• Supplement Report FDA Received Date: 06/07/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR
• Patient Weight: 118