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 Break (1069)

Patient Problem No Patient Involvement (2645)

Event Date 01/01/2019

Event Type  malfunction  

Manufacturer Narrative

Exact date of event is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is synthes sales consultant.Without a lot number the device history records review could not be completed.Product was not returned.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 Description

It was reported that on an unknown date, a reamer/irrigator/aspirator (ria) drive shaft was being disassembled by sterile processing department (spd) and when trying to remove an unknown ria reamer head from drive shaft the tongs of the drive shaft were mangled.Spd tried using pliers to remove ria head with twisting motion and mangled/broke the ria driveshaft connection.There was no patient involvement.Unknown pliers (part# unknown, lot# unknown, quantity 1).This report is for one (1) drive shaft-minimum 520mm length-for use with ria.This is report 1 of 1 for complaint (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.H3, h6: part: 314.743 synthes lot: h220887, supplier lot: h220887, release to warehouse date: may 16, 2017; june 05, 2017.Supplier: criterion tool & die, inc.There are no relevant nonconformance reports.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Visual inspection: the drive shaft-minimum 520mm length-for use with ria was received at us customer quality (cq).Visual inspection of the complaint device showed the distal tip of the device had a fragment broken off.Dimensional inspection: no dimensional inspection can be performed due to post manufacturing damage.Document/specification review: current and manufactured versions were reviewed.No design issues or discrepancies were identified.Investigation conclusion: this complaint is confirmed as the distal tip of the complaint device has a fragment broken off.No definitive root cause could be determined based on the provided information.No new, unique, or different patient harms were identified as a result of this evaluation.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.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 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

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.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: 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: 9517101
• MDR Text Key: 190648858
• Report Number: 2939274-2019-62778
• 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
• Report Date: 12/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/24/2019
• 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: H220887
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2020
• Date Manufacturer Received: 01/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNK - PLIERS