MAUDE Adverse Event Report: STRYKER TRAUMA KIEL TIBIAL NAIL, STANDARD T2 TIBIA Ø9X360 MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number 1822-0936S

Device Problems Difficult to Remove (1528); Mechanical Jam (2983)

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

Event Date 01/01/2020

Event Type  malfunction  

Manufacturer Narrative

Upon completion of investigation, additional information will be provided in a supplemental report.

Event Description

It was reported that the "tibial alignment guide in question exhibited great difficulty in attaching to the nail (via the nail holding bolts).Surgeon tried first bolt, it would not attach and nearly got permanently stuck inside the alignment handle.2nd bolt was firmly attached to the nail however could not be subsequently disassembled." surgical delay of 30-35 minutes.

Event Description

It was reported that the "tibial alignment guide in question exhibited great difficulty in attaching to the nail (via the nail holding bolts).Surgeon tried first bolt, it would not attach and nearly got permanently stuck inside the alignment handle.2nd bolt was firmly attached to the nail however could not be subsequently disassembled." surgical delay of 30-35 minutes.

Manufacturer Narrative

The reported event could be confirmed, since the device was returned for evaluation and matches the alleged failure.The device inspection revealed the following: the nail is received in an assembled condition, and no visual damage was observed over the nail surface.Since, all the 3 devices were stuck together, a functional inspection was not possible.The received devices were not possible to disassemble, therefore a definitive root cause could not be determined.The alleged event is most likely caused due to an oblique insertion/cross threading/some debris inside the hole.The investigation of the parts involved indicates that it is likely that the observed issue of seizing of the nail holding screw is possible, if an unfavorable constellation of several dimensions (extreme value and specific direction) meet when assembling the devices.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time a review of the labeling did not indicate any abnormalities.If any further information is provided, the investigation report will be reassessed.

• Brand Name: TIBIAL NAIL, STANDARD T2 TIBIA Ø9X360 MM
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; DE D-24232
• MDR Report Key: 9644228
• MDR Text Key: 178746357
• Report Number: 0009610622-2020-00035
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 04546540197795
• UDI-Public: 04546540197795
• Combination Product (y/n): N
• PMA/PMN Number: K003018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 03/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2021
• Device Model Number: 1822-0936S
• Device Catalogue Number: 18220936S
• Device Lot Number: K05A9FE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2020
• Initial Date Manufacturer Received: 01/02/2020
• Initial Date FDA Received: 01/29/2020
• Supplement Dates Manufacturer Received: 02/17/2020
• Supplement Dates FDA Received: 03/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1