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

Model Number	298.803S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).The investigation could not be completed; no conclusion could be drawn, as no product was received.A review of the device history records has been requested.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 a patient had an original open reduction internal fixation (orif) of a periprosthetic fracture of total hip stem on (b)(6) 2018.A long broad curved plate was used with cables to fix the fracture.Patient later suffered a new fracture distal to the plate and the surgeon revised the original plate by removing it and replacing it with a 4.5 va-lcp curved condylar plate and cables on (b)(6) 2018.The original construct did not fail.It was removed to revise to a new plate.There was no surgical delay.The procedure was completed successfully.Patient disposition is unknown.This report is for a 4.5 threaded cerclage positioning pin.This is report 4 of 10 for (b)(4).
Additional Manufacturer Narrative
Depuy synthese is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthese has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthese or its employees that the report constitutes an admission that the device, depuy synthese, or its employees caused or contributed to the potential event described in this report.A device history record review was performed for the subject device: brandywine dhr review product code: 289.803y lot number: h466680 manufacturing site: brandywine supplier dhr: n/a release to warehouse (monument): (b)(6) 2017 no ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any subcomponents, which would contribute to this complaint condition.,: an evaluation was performed: product was not returned.A review of the provided photos is unable to confirm the reported condition of infection.Additionally, there are no issues with the product that were able to be identified from the received photos.No issues were identified during the device history review.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 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: 4.5 THREADED CERCLAGE POSITIONING PIN
• 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: 7487447
• Report Number: 2939274-2018-52014
• Device Sequence Number: 13966401
• Product Code: JDQ
• UDI-Device Identifier: 10886982182531
• UDI-Public: (01)10886982182531
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K992891
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• 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): 04/12/2018

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 Model Number: 298.803S
• Device Catalogue Number: 298.803Y
• Device Lot Number: H466680
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/12/2018
• Supplement Date Received by Manufacturer: 06/08/2018
• Initial Report FDA Received Date: 05/04/2018
• Supplement Report FDA Received Date: 06/08/2018
• 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: 83 YR
• Patient Weight: 80