MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 3.5MM LOCKING SCREW; APPLIANCE,FIXATION,NAIL

Catalog Number 213.026S

Device Problem Failure to Cut (2587)

Patient Problem No Code Available (3191)

Event Date 06/01/2020

Event Type  malfunction  

Manufacturer Narrative

Reporter is company representative.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.(b)(4).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 on (b)(6) 2020 that during a procedure the 3.5 mm cortex and locking screws are not self-tapping correctly.There were 15 minutes delays, but it was unknown the procedure was completed successfully.There were no patient consequences.This complaint involves four (4) devices.This report is for (1) 3.5mm locking screw.This is report 4 of 4 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.A device history record (dhr) review was conducted: device history lot part: 213.026s.Lot: 3l77136.Manufacturing site: (b)(4).Release to warehouse date: (b)(6) 2019.Expiry date: march 01, 2029.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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

There was one (1) screw involved.The surgeon spoke in general about similar issues previously.

• Brand Name: 3.5MM LOCKING SCREW
• Type of Device: APPLIANCE,FIXATION,NAIL
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 10201370
• MDR Text Key: 196648542
• Report Number: 8030965-2020-04485
• Device Sequence Number: 1
• Product Code: KTT
• UDI-Device Identifier: 07611819281448
• UDI-Public: (01)07611819281448
• Combination Product (y/n): N
• PMA/PMN Number: K000684
• 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: 06/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 213.026S
• Device Lot Number: 3L77136
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/09/2020
• Patient Sequence Number: 1
• Treatment: UNK - SCREWS: CORTEX; UNK - SCREWS: CORTEX