MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC DRIVE SHAFT F/RIA 2 L520; REAMER

Model Number 03.404.035

Device Problem Break (1069)

Patient Problem Non-union Bone Fracture (2369)

Event Date 07/26/2022

Event Type  Injury  

Event Description

It was reported that on (b)(6) 2022, ria 2 shaft with grafting of a non union site tibia.A new shaft was obtained from another facility.Metal shards were removed from the tibial canal.The surgeon had a metal portion break off into the patient twice and had to stop and remove the pieces.The patient outcome was unknown.There was 1 hour of surgical delay.The procedure was completed successfully.This report is for one (1) drive shaft for ria 2 520mm.This is report 1 of 1 for complaint (b)(4).

Manufacturer Narrative

Product complaint # (b)(4).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.Device available for evaluation: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.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.

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.Part# 03.404.035.Synthes lot# j008354.Supplier lot# j008354.Release to warehouse date: 01 jun 2022, 25 jun2022, 13 jul2022.Supplier: (b)(4).No non-conformance reports were generated during production.The product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that there was no damage or defects with the drive shaft f/ria 2 l520.A dimensional inspection was performed for the drive shaft f/ria 2 l520 and met specifications.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was not confirmed as the drive shaft f/ria 2 l520 was found to have no damage or defects.No definitive root cause could be determined.There was no indication that a design or manufacturing issue contributed to the complaint.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.Drawing/specifications reviewed: the following source controlled drawings reflecting the current and manufactured revisions were reviewed: -drive shafth ria 2 03_404_035 rev.A (current and manufactured) -auger ria 2: 03_404_035_07 rev.A (current and manufactured) dimensional inspection: drawing: 03_404_035_07 rev.A feature: auger outer diameter specification measured dimension device used:(b)(6) 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: DRIVE SHAFT F/RIA 2 L520
• Type of Device: REAMER
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 15300741
• MDR Text Key: 298674891
• Report Number: 2939274-2022-03328
• Device Sequence Number: 1
• Product Code: HTO
• UDI-Device Identifier: 07612334143037
• UDI-Public: (01)07612334143037
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K11437
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 03.404.035
• Device Catalogue Number: 03.404.035
• Device Lot Number: J008354
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/03/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/25/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male