MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 5.0MM LOCKING SCREW SLF-TPNG WITH T25 STARDRIVE RECESS 18MM; SCREW, FIXATION, BONE

Catalog Number 212.203

Device Problem Unintended Movement (3026)

Patient Problem Pain (1994)

Event Type  Injury  

Manufacturer Narrative

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 reports an event in (b)(6) as follows: it was reported that a patient underwent a surgical procedure on an unknown date, more than a year ago.The patient experienced persistent pain, and x-ray images taken showed screw failure.Concomitant device reported: unknown plate, (part # unknown, lot # unknown, quantity unknown).This is report 8 of 10 for (b)(4).This complaint has been updated with the 10 of 13 devices.Please see the linked complaint (b)(4) for the additional two devices.

Event Description

Updated event description: it was reported the screws securing a plate appeared deformed.The revision occurred on (b)(6) 2019 and was completed successfully.All hardware was removed.No surgical delay.Patient was listed as stable.It is unknown what the patient was revised to.Concomitant device reported: lcp plate (part # 226.631, lot # unknown, quantity unknown).

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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Complainant part is not expected to be returned for manufacturer review/investigation.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.

• Brand Name: 5.0MM LOCKING SCREW SLF-TPNG WITH T25 STARDRIVE RECESS 18MM
• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 9396238
• MDR Text Key: 168796034
• Report Number: 8030965-2019-70638
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 07611819124691
• UDI-Public: (01)07611819124691
• Combination Product (y/n): N
• PMA/PMN Number: K000682
• 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: 11/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 212.203
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/09/2019
• Initial Date FDA Received: 12/02/2019
• Supplement Dates Manufacturer Received: 12/05/2019
• Supplement Dates FDA Received: 12/24/2019
• Patient Sequence Number: 1
• Treatment: LCP 4.5/5 BROAD 13HO L242 SST
• Patient Outcome(s): Required Intervention