MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 3.5MM TI LOCKING SCREW SELF-TAPPING 35MM; APPLIANCE,FIXATION,NAIL/BLADE/PLATE COMBO, SINGLE COMPONENT

Catalog Number 413.035S

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

Patient Problem Unspecified Infection (1930)

Event Date 01/01/2018

Event Type  Injury  

Manufacturer Narrative

Patient height reported as 175.0 cms.Patient identifier not available for reporting.Date of event reported as 2018, exact date patient infection began is not known.Additional product code: ktt.Complainant part is not expected to be returned for manufacturer review/investigation.A review of the device history records has been requested.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 patient underwent a procedure for a closed fracture of the tibia¿s diaphysis by a reduction and an osteosynthesis with tibial and fibular plates on (b)(6) 2018.Removal of the osteosynthesis material and placement of an external fixation were necessary due to scar flow.Patient was returned to surgery on (b)(6) 2018 for hardware removal.To remove the plates, surgeon cut the plates because two (2) screws had defective thread.Surgery was completed with a delay of approximately 2 hours.Patient status reported as stable.Patient is being treated with antibiotherapy for an osteoarticular infection.The defective screws are addressed in (b)(4).Patient infection is addressed in related complaints (b)(4).This report is for one (1) 3.5mm locking screw.This is report 11 of 12 for (b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H11 corrected data: b1, b5, h1: the initial complaint was reviewed and found not reportable.An incorrect quantity was initially captured.Too many parts were added to this complaint.The complaints have been updated to reflect the correct # of implanted parts associated with the reported adverse event.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 TI LOCKING SCREW SELF-TAPPING 35MM
• Type of Device: APPLIANCE,FIXATION,NAIL/BLADE/PLATE COMBO, SINGLE COMPONENT
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7913903
• MDR Text Key: 121872206
• Report Number: 8030965-2018-56761
• Device Sequence Number: 1
• Product Code: KTW
• UDI-Device Identifier: 07611819268616
• UDI-Public: (01)07611819268616
• Combination Product (y/n): N
• PMA/PMN Number: K011815
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 413.035S
• Device Lot Number: L755679
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/18/2018
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 36 YR
• Patient Weight: 70