MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH TI LCP PROX LATERAL TIBIA PL 9 HOLES/220MM/RIGHT-STERILE; PLATE,FIXATION,BONE

Catalog Number 422.224S

Device Problem Failure to Align (2522)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/26/2018

Event Type  malfunction  

Manufacturer Narrative

Patient information was not provided for reporting.Date of implant is an unknown date in 2009.Device is not expected to be returned for manufacturer review/investigation.Device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer.Additionally, device history records review could not be completed without lot number.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 europe reports an event in (b)(6) as follows: it was reported that on an unknown date in 2009, the lcp (locking compression plate) was applied to tibia diaphysis fractures.On (b)(6) 2018, patient underwent the scheduled removal surgery was performed.During the surgery, a screw which had been fixed in hole c was stuck in the screw hole.The surgeon broke its screw head with the carbide drill, and could remove the lcp plate.Then, the surgery was completed within a 30-minute delay.There was no adverse consequence to the patient.This report is for one (1) ti lcp prox lateral tibia pl 9 holes/220mm/right-sterile.This is report 1 of 2 for (b)(4).

• Brand Name: TI LCP PROX LATERAL TIBIA PL 9 HOLES/220MM/RIGHT-STERILE
• Type of Device: PLATE,FIXATION,BONE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK GRENCHEN (CH); solothurnstrasse 186; grenchen 2540 ; SZ 2540
• Manufacturer Contact: michael cote ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7433082
• MDR Text Key: 105570109
• Report Number: 8030965-2018-53120
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 07611819289529
• UDI-Public: (01)07611819289529
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K052390
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 03/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 422.224S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/26/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1