MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH TROCAR WITH HANDLE FOR USE WITH 03.120.014; GUIDE, SURGICAL, INSTRUMENT

Catalog Number	03.120.015
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
Additional 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 (b)(6) reports an event as follows: it was reported on an unknown date that the locking/neutral guide outer locking tabs no longer lock into the black aiming arm.They have essentially been stripped and are no longer usable.The trocar with handle locking tabs are also stripped and no longer connect to the locking/neutral guides.No further information is available.Concomitant devices: unk - guides/sleeves/aiming: aiming arm (part# unknown; lot# unknown; quantity: unknown) unk - guides/sleeves/aiming: guide (part# unknown; lot# unknown; quantity: unknown) this report is for one (1) trocar with handle for use with 03.120.014.This is report 2 of 2 for (b)(4).

• Brand Name: TROCAR WITH HANDLE FOR USE WITH 03.120.014
• Common Device Name: GUIDE, SURGICAL, INSTRUMENT
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 10431195
• Report Number: 8030965-2020-06175
• Device Sequence Number: 2889479
• Product Code: FZX
• UDI-Device Identifier: 07611819970137
• UDI-Public: 07611819970137
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/27/2020

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: 03.120.015
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/27/2020
• Initial Report FDA Received Date: 08/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1