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 Codes	Break (1069); Material Deformation (2976)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	03/05/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device used for treatment, not diagnosis.No patient information will be reported.Device is an instrument and is not implanted/explanted.Device history records review was conducted.The report indicates that the: device history lot / part no.: 03.111.600, lot no.: 14-0288.Manufacturing location: (b)(6).Supplier: (b)(6).Release to warehouse date: 30.Jan.2015.No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Investigation summary: reviewing dhr shows that the affected lot was released after complete final inspection with no detected issues regarding manufacturing procedure.This device was released in faultless condition.For details, please see appropriate section device history.The investigation of the complained guiding block shows that the set screw is broken off.Microscopic investigation shows that the broken surface is homogeneous what indicates material conformity.Also circular lines on the broken surface also indicate torsional stress while applying exceeding mechanical force during use.It also could be identified that the shaft of the set screw is practically deformed in the area of the breakage.Due to this deformation / elongation in longitudinal direction it is no longer possible to measure the relevant dimension.As result of this facts, we can exclude manufacturing related issue for this breakage.No product failure could be identified.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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
It was reported, that on (b)(6) 2018, the following device was used in the open reduction internal fixation (orif) surgery for distal radius fracture (right).Guiding block f/2-column dist-rad-pl2.4 6.During the surgery, the guiding block attachment screw broke at the time of fixation to the small plate.However, fixation to the extra-small plate was successful.The surgery was completed with a less-than-30-minute delay, and there was no adverse consequence to the patient.This complaint involves 1 part.This report is 1 of 1 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: 7391000
• Report Number: 8030965-2018-52688
• Device Sequence Number: 19251922
• Product Code: FZX
• UDI-Device Identifier: 07611819352520
• UDI-Public: (01)07611819352520(10)14-0288
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 03/05/2018

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: 14-0288
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2018
• Initial Date Received by Manufacturer: 03/05/2018
• Initial Report FDA Received Date: 04/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1