MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH VEPTR NUT DRIVER SHAFT 6MM HXC; MISC ORTHO SURGICAL INSTR

Catalog Number	03.641.003
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.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 or Problem Description
Device report from synthes reports an event in (b)(6) as follows: it was reported that on an unknown date, the nut driver shaft was sticking when engaging.The tip of the inner pin is bent and can prevent alignment.It was mentioned that the device was used five (5) times happened in 2018 during cases.There was a few minutes dealt while they aligned it.Procedure outcome is unknown.No patient harm.This is report 1 of 1 for (b)(4).This complaint is linked to (b)(4) which captures the veptr nut driver shaft was noticed that tip was bent and the following (b)(4) capture the intraoperative usage.
Event or Problem Description
This complaint is linked to this (b)(4).As it captures the 4th complaint of the veptr nut driver shaft 6 that was used out of five (5) times happened in 2018 during cases.All product complaint follow up will be captured under (b)(4).
Additional 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.Event: additional information provided for reporting.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: VEPTR NUT DRIVER SHAFT 6MM HXC
• Common Device Name: MISC ORTHO SURGICAL INSTR
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 9217910
• Report Number: 8030965-2019-69517
• Device Sequence Number: 19579674
• Product Code: LXH
• UDI-Device Identifier: 07611819353756
• UDI-Public: (01)07611819353756
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 03.641.003
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/30/2019
• Supplement Date Received by Manufacturer: 10/17/2019
• Initial Report FDA Received Date: 10/22/2019
• Supplement Report FDA Received Date: 11/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1