MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 3.5MM LCP MEDIAL PROXIMAL TIBIA PLATE 8H/RIGHT 145MM PLATE, FIXATION, BONE

Catalog Number 239.958

Device Problem Use of Device Problem (1670)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/13/2020

Event Type  malfunction  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation. Reporter is a j&j employee. A device history record (dhr) review was conducted: part number: 239. 958, lot number: 57p7002, part manufacture date: 02-jun-2020, manufacturing location: (b)(4), part expiration date: n/a, nonconformance noted: n/a. Dhr record review: a review of the device history record revealed no complaint related anomalies. The device history record shows this lot of lcp med prox-tibpl 3. 5 r shaft 8ho l145 product was processed through the normal manufacturing and inspection operations with no rework nor nonconformities noted. This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition. A review of the raw material device history record revealed this lot met all specifications with no nonconformance noted. This raw material lot met all dimensional and visual criteria at the time of manufacture with no issues documented during the manufacture that would contribute to this complaint condition. The investigation could not be completed; no conclusion could be drawn, as no product was received. 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 Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that the during a right femur osteosynthesis procedure performed on (b)(6) 2020, while fixing the lateral part of the femur with a condylar support plate, the surgeon stated that he must also fix the femur medially and decides to use a 3. 5 proximal right medial tibial plate since at that time there was no other option available. The procedure was successfully completed. No further information provided. This report is for one (1) 3. 5mm lcp medial proximal tibia plate 8h/right 145mm. This is report 1 of 1 for complaint (b)(4).

• Brand Name: 3.5MM LCP MEDIAL PROXIMAL TIBIA PLATE 8H/RIGHT 145MM
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): ELMIRA; 35 airport road; horseheads NY 14845
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 10804583
• MDR Text Key: 215350551
• Report Number: 8030965-2020-08735
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K050646
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 10/13/2020

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 11/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: 239.958
• Device Lot Number: 57P7002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 11/09/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/02/2020
• Is the Device Single Use?: Yes

Is This a Reprocessed and Reused Single-Use Device?

• Type of Device Usage: Unkown