MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH; SCREW,FIXATION,BONE

Device Problem Separation Failure (2547)

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

Event Date 12/06/2017

Event Type  malfunction  

Manufacturer Narrative

Patient information is not available for reporting.This report is for seven (7) unknown locking screws.Potential part numbers are 412-1xxs.Specific part and lot numbers are unknown.Without the specific part and lot number, the udi is not available.Implanted in 2013; exact date is unknown.Could not be explanted during the hardware removal surgery on (b)(6) 2017.Complainant device is not expected to be returned for manufacturer review/investigation.(510k): unknown.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 a locking compression anterolateral distal tibial plate and screws were implanted in 2013.In (b)(6) 2017, during the scheduled removal surgery, the plate could not be removed because all of the seven (7) locking screws got stripped.The surgeon closed a surgical incision without removing the plate with a 120-minute extension.The surgeon commented that he will consider whether the removal surgery can be performed again.Concomitant device reported: 3.5 mm lcp anterolateral distal tibia plate (part # 441-4xxs, lot # unknown, quantity 1).This report is for seven (7) unknown locking screws.This is report 1 of 1 for complaint (b)(4).

• Type of Device: SCREW,FIXATION,BONE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7160279
• MDR Text Key: 96992897
• Report Number: 8030965-2018-50030
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 12/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/06/2017
• 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