MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH DRIVE SHAFT FOR RIA 2 520MM; ACCESSORIES, ARTHROSCOPIC

Catalog Number 03.404.035

Device Problem Break (1069)

Patient Problems Foreign Body In Patient (2687); No Code Available (3191)

Event Date 09/02/2020

Event Type  Injury  

Manufacturer Narrative

Additional product code: hto.Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.(b)(4).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

Device report from (b)(6) reports an event as follows: it was reported on (b)(6) 2020 that the patient underwent for a procedure for tibial ria 2 washout infection.During the procedure, one driver was broken while trying to ream down the canal and another driver, the shaft of the reamer broke inside the driver shaft.It was unknown if the procedure completed successfully.The patient outcome was unknown.Concomitant devices reported: unknown reamer (part# unknown, lot# unknown, quantity# 1).This complaint involves two (2) devices.This report is for (1) drive shaft for ria 2 520mm.This is report 2 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.Investigation summary: product was not returned.Reviewing attached picture the breakage can be confirmed.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.

• Brand Name: DRIVE SHAFT FOR RIA 2 520MM
• Type of Device: ACCESSORIES, ARTHROSCOPIC
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 10589904
• MDR Text Key: 208730469
• Report Number: 8030965-2020-07469
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 07612334143037
• UDI-Public: (01)07612334143037
• Combination Product (y/n): N
• PMA/PMN Number: K111437
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.404.035
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNK - REAMERS
• Patient Outcome(s): Required Intervention