MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH VEPTR NUT DRIVER SHAFT 6; 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
The investigation could not be completed; no conclusion could be drawn, as no product was received.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.Without a lot number the device history records review could not be completed.Product was not returned.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 catching / sticking when engaging, tip of the inner pin is bent and can prevent alignment.It was mentioned that the sales consultant wasn't present at the case, but it was used five (5) times happened in 2018 during cases and was catching/sticking when engaging.There were 9 minutes dealt while they aligned it.Procedure outcome is unknown.No patient harms.This report is for 1 of 1 for (b)(4).
Additional 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.Patient identifier: multiple patients from different events were involved.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 6
• Common Device Name: MISC ORTHO SURGICAL INSTR
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 9208641
• Report Number: 8030965-2019-69452
• Device Sequence Number: 10874863
• Product Code: LXH
• UDI-Device Identifier: 07611819353756
• UDI-Public: (01)07611819353756
• Combination Product (Y/N): N
• 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: 10/29/2019
• Initial Report FDA Received Date: 10/18/2019
• Supplement Report FDA Received Date: 11/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1