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

Catalog Number	03.111.501
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/06/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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) 2020, the patient underwent open reduction internal fixation surgery for distal radius fracture with the guiding block in question.During the surgery, the surgeon tried to pass k-wires through 2 distal holes of a plate through the guiding block, but he couldn't because the k-wires interfered with the plate.The surgeon removed them from the patient, and checked them, but the k-wires would not pass through 2 distal holes of the plate.The k-wires could pass through the guiding blocks hole.The surgeon passed the k-wires through the holes without the use of the guiding block, and the surgery was continued.The surgery was completed successfully with a thirty (30) minute delay.The patient status after the procedure was stable.Concomitant devices reported: plates: trauma (part number unknown, lot unknown, quantity 1), guide/compression/k-wires trauma (part number unknown, lot unknown, quantity unknown).This report involves one (1) guide block for two-column plate/narrow 6h hd/lt.This is report 1 of 2 for (b)(4).
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H3, h4, h6: dimensions and positions were measured -all the features resulted inside the specifications; therefore, the test was passed.Since the device ¿guiding block f/2-column dist-rad-pl2.4 n¿ 03.111.501 with lot number 9770569 passed all the test related to dimensions and positions and in particular those related with the guiding block holes, it is not possible to replicate the complaint.According to evidences is not possible to address the final root cause to a manufacturing issue.The manufacturing process was performed according to the reviewed documents and all functional test were recorded.Most likely a mishandling of the device could have led to the opening of this complaint.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed as no product related issue could be detected.Device history lot part: 03.111.501, lot: 9770569, manufacturing site: hägendorf, release to warehouse date: 09.Feb.2016.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances 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.

• Brand Name: GUIDE BLOCK FOR TWO-COLUMN PLATE/NARROW 6H HD/LT
• Common Device Name: GUIDE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 9929286
• Report Number: 8030965-2020-02604
• Device Sequence Number: 2742335
• Product Code: FZX
• UDI-Device Identifier: 07611819394414
• UDI-Public: (01)07611819394414
• 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,Followup
• Report Date (Section B): 03/09/2020

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: 03.111.501
• Device Lot Number: 9770569
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2020
• Initial Date Received by Manufacturer: 03/09/2020
• Supplement Date Received by Manufacturer: 04/15/2020
• Initial Report FDA Received Date: 04/06/2020
• Supplement Report FDA Received Date: 04/30/2020
• 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 - GUIDE/COMPRESSION/K-WIRES; UNK - PLATES