MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH GUIDE BLOCK FOR 2 COLUMN PLATE 6 HOLE HEAD/RIGHT

Catalog Number	03.111.600
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
Part 03.111.600, lot 11-9391: manufacturing site: (b)(4).Supplier: (b)(4).Release to warehouse date: july 11, 2011.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.A product investigation was completed: six (6) guiding blocks were returned by customer complaining that the set screws are too long.Parts were forwarded to the responsible product development center for evaluation.The visual inspection confirmed that the shaft of the set screws is twisted - this can be seen by the shape of the laser etching.The review of the production history revealed that all of these guiding blocks were manufactured according to the specifications.The parts conformed to dimensional specifications at the time of manufacturing and passed inspection requirements.Furthermore, these instruments are function checked per 100% before they leave the manufacturing site.A review and measurement of the returned parts showed that the screws were overloaded, which led to the twisted and extended shaft of the screw.This extension caused the set screws to protrude the bottom of the plate, which prevented proper placement of the plate on the bone.These are not fixation screws but only set screws that are not suitable for high loads.Therefore, the design does not contribute to the reported failure.By over-tightening the set screws, the user elongated the screw shaft.No manufacturing or design related issues that would have contributed to this complaint were found; the damage occurred is determined to be post production/acceptance criteria's.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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 (b)(4) reports an event as follows: it was reported that during an unknown procedure on an unknown date, six (6) guiding blocks for a variable angle locking compression plate (va-lcp) two column distal radius plate did not fit correctly on two (2) plates.A screw to fix the guiding blocks on the plate was too long resulting in the plate not being placed properly on the bone.It is unknown if there was a surgical delay.The procedure was successfully completed using a plate with no guiding block.There was no patient harm or intervention required this report is for a va-lcp plate.This is report 4 of 8 for (b)(4).

• Brand Name: GUIDE BLOCK FOR 2 COLUMN PLATE 6 HOLE HEAD/RIGHT
• Common Device Name: GUIDE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 8628995
• Report Number: 8030965-2019-64274
• Device Sequence Number: 13965273
• Product Code: FZX
• UDI-Device Identifier: 07611819352520
• UDI-Public: (01)07611819352520
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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): 03/12/2019

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: 03.111.600
• Device Lot Number: 11-9391
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/23/2019
• Initial Report FDA Received Date: 05/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1