MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 30MM F/IM NAIL-STER; SCREW, FIXATION, BONE

Catalog Number 04.005.520S

Device Problems Dull, Blunt (2407); Device Operates Differently Than Expected (2913)

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

Event Date 05/10/2018

Event Type  malfunction  

Manufacturer Narrative

Additional narrative: patient information is not available for reporting.Due to the intra-operative events, the device was not successfully implanted.An alternate device was used to complete procedural step.As such, implant/explant dates are not applicable.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.The subject device has been received and the product evaluation is in progress.No conclusion can be drawn.A review of the device history records has been requested and is currently pending completion.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 during an open reduction internal fixation (orif) surgery performed on (b)(6) 2018, surgeon had a difficulty inserting a locking screw as compared to the previously inserted screw.Then, it was found that a portion of the screw¿s threads in question did not look normal.Surgeon replaced the screw.Surgery was prolonged for a 30-minute due to the screw replacement.No fragments generated.There was no adverse consequence to the patient.(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.Sterile part 04.005.520s, lot l730234: manufacturing location: (b)(4).Supplier:(b)(4).Release to warehouse date: january 16, 2018.Expiry date: january 01, 2028.Non-sterile part 04.005.520, lot l705879: manufactured in (b)(4).Release to warehouse date: january 03, 2018.No non-conformance reports (ncrs) were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.A product investigation was completed: visual inspection shows that the locking screw came in strong contact with the nail during insertion.Post manufacturing damages could be identified.The tip of the screw is deformed as result of touching the nail hardly.Also, the thread of the screw is plastically deformed what also indicates contact with the nail.Further also the torx recess shows clear signs of deformation / wear and tear as result of exceeding applied mechanical force while insertion.All those signs are clear indication of misalignment during insertion.The screw was not properly aligned with the locking hole of the nail, therefore the screw touched the nail and got damaged.No product fault could be identified.This is clearly a use error which caused the complained condition.As we could replicate the complaint condition, this complaint is classified as confirmed.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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 TI LOCKING SCREW W/T25 STARDRIVE 30MM F/IM NAIL-STER
• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7556752
• MDR Text Key: 109645416
• Report Number: 8030965-2018-54051
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 07611819789784
• UDI-Public: (01)07611819789784
• Combination Product (y/n): N
• PMA/PMN Number: K172157
• 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: 05/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.005.520S
• Device Lot Number: L730234
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2018
• Date Manufacturer Received: 06/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1