MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC INTERLOCKING BOLT FOR 4.5MM VA-LCP CONDYLAR INSERTN HANDLE; IMPLANT, FIXATION DEVICE, CONDYLER PLATE

Model Number 03.231.005

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Reporter: synthes employee.The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.Additional product codes: hwc, hrs.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 (b)(6) 2019, one of my partners and myself were going over the variable angle condylar system and were hooking up 14 hole left plate to the aiming jig as a practice run.It seemed that the plate was not connecting correctly to the bolt and maybe bolt or plate is damaged.There was no patient involvement.Concomitant device reported: unknown insertion handle (part # unknown, lot # unknown, quantity # 1).This is report 1 of 2 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H3, h4, h6: the interlocking bolt for 4.5mm va-lcp condylar insertn handle (part # 03.231.005 lot # 9921301) was received at us cq.There are light surface scratches along the shaft of the device but no other obvious issues.Under magnification, the threads of the device show slight signs of wear, but not enough that would impact the functionality of the device.The interlocking bolt failed to tighten onto the first combi-hole of the va-lcp curved condylar plate (hole that is the first hole proximal to the condylar plate region).Further testing showed that the interlocking bolt was able to tighten to the rest of the 13 holes of the va-lcp curved condylar plate.Only the noted hole failed functional testing.Due to the interlocking bolt locking to the other holes of the plate, it seems that the defect is isolated to the first combi-hole of the plate and there is no defect with the interlocking bolt.The complaint was not confirmed for the interlocking bolt for 4.5mm va-lcp condylar insertn handle (part # 03.231.005 lot # 9921301).Although the device was not able to secure to the first combi-hole of the va-lcp plate, the device was able to secure to the other 13 holes of the plate.The defect is isolated to the first hole of the plate.No visual or dimensional issues were found with the interlocking bolt.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Device history lot part: 03.231.005; lot number: 9921301; manufacturing site: hägendorf; release to warehouse date: 10.June 2016.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which 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.

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.H10 additional narrative: h3, h4, h6: a review of the device history record 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.

• Brand Name: INTERLOCKING BOLT FOR 4.5MM VA-LCP CONDYLAR INSERTN HANDLE
• Type of Device: IMPLANT, FIXATION DEVICE, CONDYLER PLATE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8930779
• MDR Text Key: 195553063
• Report Number: 2939274-2019-60084
• Device Sequence Number: 1
• Product Code: JDP
• UDI-Device Identifier: 10886982077325
• UDI-Public: (01)10886982077325
• Combination Product (y/n): N
• PMA/PMN Number: K110354
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 07/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 03.231.005
• Device Catalogue Number: 03.231.005
• Device Lot Number: 9921301
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2019
• Date Manufacturer Received: 09/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNK - GUIDES/SLEEVES/AIMING: GUIDE