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

Model Number	1822-0936S
Medical Device Problem Codes	Difficult to Remove (1528); Mechanical Jam (2983)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
Event or Problem 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 or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 0009610622-2020-00035
• Device Sequence Number: 19457955
• Product Code: HSB
• UDI-Device Identifier: 04546540197795
• UDI-Public: 04546540197795
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K003018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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 Received by Manufacturer: 01/02/2020
• Supplement Date Received by Manufacturer: 02/17/2020
• Initial Report FDA Received Date: 01/29/2020
• Supplement Report FDA Received Date: 03/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1