MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 2.4MM VA-LCP 2-CLMN VLR DSTL RADIUS PL 7H HD/3H SHAFT/RIGHT; PLATE, FIXATION ,BONE

Model Number	02.111.730
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/17/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product was not returned.Based on the information available, it has been determined that no corrective and/or 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: 02.111.730.Lot: 2l32612.Manufacturing site: raron.Release to warehouse date: 26.Nov.2018.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, distal radius osteosynthesis surgery was performed with the placement of distal radio plate.It was fixed by placing a locking screw in the lateral distal hole of the plate which did not allow the locking.The procedure was completed without complication.This report is for one (1) 2.4mm va-lcp 2-clmn vlr dstl radius pl 7h hd/3h shaft/right.This is report 1 of 2 for (b)(4).

• Brand Name: 2.4MM VA-LCP 2-CLMN VLR DSTL RADIUS PL 7H HD/3H SHAFT/RIGHT
• Common Device Name: PLATE, FIXATION ,BONE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 9611286
• Report Number: 8030965-2020-00494
• Device Sequence Number: 13578982
• Product Code: HRS
• UDI-Device Identifier: 10886982032294
• UDI-Public: (01)10886982032294
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K063049
• 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): 12/27/2019

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 Model Number: 02.111.730
• Device Catalogue Number: 02.111.730
• Device Lot Number: 2L32612
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/27/2019
• Initial Report FDA Received Date: 01/21/2020
• Patient Sequence Number: 1