MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH GUIDE BLOCK FOR TWO-COLUMN PLATE/NARROW 6H HD/RT

Catalog Number	03.111.500
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/30/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pma/510k: device is not distributed in the united states, but is similar to device marketed in the usa.Investigation summary: 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 history lot , part: 03.111.500, lot: 3725560, manufacturing site: (b)(4), release to warehouse date: april 11, 2011.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance's were identified.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 (b)(6) 2019, the patient underwent the osteosynthesis surgery for right distal radius with a va two-column plate and the guiding block in question.During the surgery, the surgeon tried to connect the guiding block to the plate.When turned the screw of the guiding block with a screwdriver, the screw part of the guiding block broke.The surgeon drilled the distal screw hole with a drill sleeve because he could not use the guiding block, and the surgery was completed successfully.There was no surgical delay.Concomitant devices reported: unknown plates (part# unknown, lot# unknown, quantity# 1).Unknown screwdrivers (part# unknown, lot# unknown, quantity# 1).This is report 1 of 1 for (b)(4).

• Brand Name: GUIDE BLOCK FOR TWO-COLUMN PLATE/NARROW 6H HD/RT
• Common Device Name: GUIDE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 9336535
• Report Number: 8030965-2019-70365
• Device Sequence Number: 14107294
• Product Code: FZX
• UDI-Device Identifier: 07611819394407
• UDI-Public: (01)07611819394407
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 11/01/2019

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: 03.111.500
• Device Lot Number: 3725560
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/01/2019
• Initial Report FDA Received Date: 11/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1