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 Consequences Or Impact To Patient (2199)

Event Date 12/05/2018

Event Type  malfunction  

Manufacturer Narrative

Device is not expected to be returned for manufacturer review/investigation.Product was not returned.Based on the information available, it has been determined that no corrective and 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 (b)(6) 2018, on an unknown procedure, the tip of the drive shaft broke off.The procedure and surgical delay is unknown.Patient and surgery outcome are unknown.This report is for one (1) drive shaft.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.Corrected data: date of this report.Reporter's name.The incorrect date received by mfr date was inadvertently utilized in initial medwatch.The correct date is december 6, 2018.  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: 8207160
• MDR Text Key: 131801045
• Report Number: 2939274-2018-55653
• 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,health
• Type of Report: Initial,Followup
• Report Date: 12/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2018
• 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
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1