MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 3.5MM VA-LCP PROX TIBIA PLATE LARGE BEND/4H/87MM/LEFT; PLATE, FIXATION, BONE

Model Number	02.127.311
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/07/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional procode: hwc.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a synthes employee.Without a lot number the device history records review could not be completed.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 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 (b)(6) reports an event as follows: it was reported that patient underwent surgery for a medial tibial plateau fracture with a posterior stroke of the right leg.The specialist chose the variable angle locking compression plate (va lcp) 3.5 p / proximal tibia large left curved 4-hole plate, which is indicated for the antero-lateral plate of the corresponding side, because it was better suited than the right and posterior medial plates.It was fixed with 2 variable angle screws, a locked screw and a 3.5 mm conical screw, all in the proximal part and in the diaphyseal part with 2 cortical screws and one locked, supported by 1 cortical screw of 3.5 mm of interfragmentary compression and another 3.5 mm cortical screw, supported by a 3.5 / 4.0 mm screw washer.This report is for a 3.5mm va-lcp proximal tibia plate.This is report 1 of 1 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.A1: additional patient identifier: (b)(6).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: 3.5MM VA-LCP PROX TIBIA PLATE LARGE BEND/4H/87MM/LEFT
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 10614568
• Report Number: 8030965-2020-07623
• Device Sequence Number: 11372459
• Product Code: HRS
• UDI-Device Identifier: 10886982043825
• UDI-Public: (01)10886982043825
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K120689
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/08/2020

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 Model Number: 02.127.311
• Device Catalogue Number: 02.127.311
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/08/2020
• Supplement Date Received by Manufacturer: 10/06/2020
• Initial Report FDA Received Date: 10/01/2020
• Supplement Report FDA Received Date: 11/02/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 3.5MM CONICAL SCREW SLF-TPNG FULLY THREADED 75MM; 3.5MM CORTEX SCREW SELF-TAPPING 50MM; 3.5MM LOCKING SCREW SLF-TPNG 50MM; 3.5MM LOCKING SCREW SLF-TPNG 60MM; 3.5MM STARDRIVE CORTEX SCREW SELF-TAPPING 34MM; 3.5MM STARDRIVE CORTEX SCREW SELF-TAPPING 40MM; 3.5MM STARDRIVE CORTEX SCREW SELF-TAPPING 45MM; 3.5MM CONICAL SCREW SLF-TPNG FULLY THREADED 75MM; 3.5MM CORTEX SCREW SELF-TAPPING 50MM; 3.5MM LOCKING SCREW SLF-TPNG 50MM; 3.5MM LOCKING SCREW SLF-TPNG 60MM; 3.5MM STARDRIVE CORTEX SCREW SELF-TAPPING 34MM; 3.5MM STARDRIVE CORTEX SCREW SELF-TAPPING 40MM; 3.5MM STARDRIVE CORTEX SCREW SELF-TAPPING 45MM
• Patient Age: 39 YR