MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 5.0MM TI LOCKING HEAD SCREW SELF-TAPPING 60MM; APPLIANCE, FIXATION, NAIL

Catalog Number 413.360

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Wound Dehiscence (1154); Skin Erosion (2075)

Event Date 01/01/2018

Event Type  Injury  

Manufacturer Narrative

Exact date of event is unknown; event reportedly occurred in 2018.It is unknown if the complainant part is available to be returned for manufacturer review/investigation, but it has yet to be received.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 Description

Device report from synthes (b)(6) reports an event as follows: it was reported that on (b)(6) 2018, the patient underwent an orthopedic procedure for hardware removal of one (1) locking compression plate (lcp) proximal tibial plate, five (5) locking screws and two (2) cancellous bone screw, due to serious generalized skin fragility and dehiscence of the wound.Originally, the patient underwent an osteosynthesis of the left external tibial plate, on (b)(6) 2018.There was a fifty-five (55) minute surgical delay reported.Patient outcome was unknown.This report is for a locking screw.This is report 2 of 8 for (b)(4).

• Brand Name: 5.0MM TI LOCKING HEAD SCREW SELF-TAPPING 60MM
• Type of Device: APPLIANCE, FIXATION, NAIL
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK BETTLACH (CH); muracherstrasse 3; bettlach 2544 ; SZ 2544
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 8244233
• MDR Text Key: 132938864
• Report Number: 8030965-2019-59831
• Device Sequence Number: 1
• Product Code: KTT
• UDI-Device Identifier: 07611819240636
• UDI-Public: (01)07611819240636
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K023941
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2019
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 413.360
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/21/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention