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)
Date of Event	07/31/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reporter is j&j employee.A device history record (dhr) review was conducted: part: 03.111.600.Lot: 09-4567.Manufacturing site: (b)(4).Supplier:(b)(4).Release to warehouse date: 21.December 2009.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.A product investigation was conducted.Visual investigation: the set screw of the guiding block is broken in half.The broken of portion is available for investigation.The shaft of the broken off portion with the m2 thread is worn.The shaft diameter obviously was reduced because of frequent / forcible use.The article and batch number labeling are no longer in line because the whole screw shaft was twisted during great application of force.The guiding block is worn what is visible on the worn-out centering bores.Dimensional inspection: the screw shaft diameter was measured close to the m2 thread undamaged shaft area and referring to the relevant drawing and is withing specifications.Investigation conclusion: the guiding block was received with a broken set screw, the complaint therefore is confirmed.Our investigation proves evidence that the ten years old instrument was subjected to frequent and mechanical overload as the set screw shaft clearly got twisted before the breakage occurred.The article and batch number labeling are no longer in line because the whole screw shaft was twisted during great application of force.No manufacturing related issue was identified and/or confirmed.Based on the investigation findings, it has been determined that no corrective and/or preventative action is appropriate.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 open reduction internal fixation (orif) surgery for distal radius fracture with the guiding block.After a nurse attached the guiding block to a plate without a driver, the surgeon located the devices in the incision and fixed them temporarily with 2 k-wires.When the surgeon used a reduction forceps through the guiding block, the guiding block was unstable.After that, the guiding block attachment screw broke, and the guiding block came off.The fragment of the guiding block attachment screw remained on the plate, and the surgeon could remove it.There were no pieces left in the patient.The doctor confirmed it by x-ray.The surgery was delayed by less than thirty (30) minutes.Patient outcome reported as stable.Concomitant device reported: unk plates: trauma (part #: unknown, lot #: unknown, quantity 1), unk guide/compression/k wires: trauma (part #: unknown, lot #: unknown, quantity 1), unk forceps: trauma (part #: unknown, lot #: unknown, quantity 1).This report is for one (1) guide block for 2 column plate 6 hole head/right.This is report 1 of 2 for complaint (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: 8940444
• Report Number: 8030965-2019-67792
• Device Sequence Number: 11393306
• Product Code: FZX
• UDI-Device Identifier: 07611819352520
• UDI-Public: (01)07611819352520
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/31/2019

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: 09-4567
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/31/2019
• Initial Report FDA Received Date: 08/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - FORCEPS; UNK - GUIDE/COMPRESSION/K-WIRES; UNK - PLATES