MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC DRIVE SHAFT-MINIMUM 520MM LENGTH-FOR USE WITH RIA; REAMER

Model Number 314.743

Device Problem Material Integrity Problem (2978)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Initial reporter is synthes sales representative.Visual inspection: visual inspection of the returned device performed at customer quality (cq) confirmed the condition of post manufacturing damage, which agrees with the reported complaint condition.More specifically, the distal tip of the device has broken off just distal to the helix feature and was not returned.Dhr review: the returned device was manufactured in june 2005 and is over 13 years old.No ncrs were generated during production.Review of the device history record showed that there were no issues during the manufacture of this product, and any subcomponents, which would contribute to this complaint condition.The 314.743 ria driveshaft l520 is a reusable instrument which attaches to the corresponding length reamer/irrigator/aspirator (ria) tube assembly and a reamer head and then connected to a drive unit.The ria system is intended for use to clear the medullary canal, to size the medullary canal, to harvest bone and bone marrow, and to remove infected and necrotic bone.The distal tip of the ria driveshaft mates with the reamer head.No product design issues or discrepancies were observed during this investigation.Material analysis: the design specified the shaft component to be manufactured from nitonol 55 material.The certificate of compliance in dhr confirmed that the shaft component was manufactured from nitonol 55 material.Investigation conclusion: a definitive assignable root cause for the device breaking could not be determined based on the provided information.This complaint is confirmed however no product design issues or manufacturing discrepancies that would contribute to the reported complaint condition were identified during this investigation.No new, unique or different patient harms were identified as a result of this evaluation.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Device history lot part number: 314.743, synthes lot number: 5020042, supplier lot number: 13928-01, release to warehouse date: 07-jun-2005, expiration date: n/a, supplier: (b)(4).No ncrs were generated during production.The material was reviewed and the hardness value was confirmed to meet the specification with no (relevant) non-conformance noted.The certificate of compliance in dhr confirmed that the shaft component was manufactured from nitonal 55 material.Review of the device history record showed that there were no issues during the manufacture of this product, and any subcomponents, 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.

Event Description

It was reported that on (b)(6) 2019 during testing at service and repair, it was noticed the tip of the drive shaft was damaged.There was no patient involvement.This report is for one (1) drive shaft-minimum 520mm length-for use with ria.This is report 1 of 1 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.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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Additional data-d4 lot number.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.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-MINIMUM 520MM LENGTH-FOR USE WITH RIA
• Type of Device: REAMER
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8425534
• MDR Text Key: 139319464
• Report Number: 2939274-2019-56987
• Device Sequence Number: 1
• Product Code: HTO
• UDI-Device Identifier: 10886982189042
• UDI-Public: (01)10886982189042
• Combination Product (y/n): N
• PMA/PMN Number: K042899
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 314.743
• Device Catalogue Number: 314.743
• Device Lot Number: 5020042
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2019
• Date Manufacturer Received: 03/19/2019
• Patient Sequence Number: 1