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

Catalog Number 02.127.211

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/24/2022

Event Type  malfunction  

Event Description

Device report from depuy synthes reports an event in (b)(6) as follows: it was reported that on (b)(6), 2022 during an orthopedic procedure, the screws did not lock into the plate, they went through the hole. There was no surgical delay and patient impact. The surgery was completed successfully. This report is for one (1) 3. 5mm va-lcp prox tibia plate small bend/4h/87mm/left. This is report 7 of 8 for complaint (b)(4).

Manufacturer Narrative

Additional narrative: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received. Reporter is a j&j employee. 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.

• Brand Name: 3.5MM VA-LCP PROX TIBIA PLATE SMALL BEND/4H/87MM/LEFT
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK RARON (CH); kanalstrasse west 30; raron 3942 ; SZ 3942
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 13902722
• MDR Text Key: 288180390
• Report Number: 8030965-2022-01907
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K120689
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative

Reporter Occupation

• Type of Report: Initial,Followup,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: 02.127.211
• Device Lot Number: 444P016
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/03/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/12/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Unkown

Patient Treatment Data

Date Received: 03/25/2022 Patient Sequence Number: 1

Treatment

3.5 VA LCK SCRW/SLF-TP/STRD/36.; 3.5 VA LCK SCRW/SLF-TP/STRD/44.; 3.5 VA LCK SCRW/SLF-TP/STRD/46.; 3.5 VA LCK SCRW/SLF-TP/STRD/50.; 3.5 VA LCK SCRW/SLF-TP/STRD/54.; SCREW Ø3.5 SELF-TAP FULL-THR L60 T15 SST.; SCREW Ø3.5 SELF-TAP FULL-THR L65 T15 SST.