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 Code	Difficult or Delayed Separation (4044)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/09/2019
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
Customer reported that : "procedure: double tibia-fibula fracture.Placement of a tibial nail with a handpiece.At the end of the operation, during the removal of the handpiece, the tibial nail remained stuck on the nail holder of the ancillary.After multiple attempts, it was impossible to detach the nail from the ancillary.The surgeon was forced to explant the nail and screws put in place and perform a new bore.Change of nail with obligation to drive a bigger nail because no other nails of the same size in stock." delay : 1h opening of a new ancillary instrument set and placement of a bigger nail.
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: we received the nail, a nail holding screw and the targeter in an assembled condition for evaluation.All devices were received in a blocked mode.Disassembling of devices was undertaken with a drill drift; however, the devices were not possible to disassemble.Functional inspection: the prongs of the nail are not fully engaged in the slot of the nail adapter portion [slight visible gap - no positive-locking fit].Dimensional inspection: due to the nature of the returned device, a dimensional inspection was not possible.However, during manufacturing, functionality test and dimensional inspection were performed according to specifications.During the inspection, all devices met the specifications.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.Although, a real root cause could not be determined but 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.No indications of material, manufacturing or design related problems were found during the investigation.
Event or Problem Description
Customer reported that : "procedure: double tibia-fibula fracture.Placement of a tibial nail with a handpiece.At the end of the operation, during the removal of the handpiece, the tibial nail remained stuck on the nail holder of the ancillary.After multiple attempts, it was impossible to detach the nail from the ancillary.The surgeon was forced to explant the nail and screws put in place and perform a new bore.Change of nail with obligation to drive a bigger nail because no other nails of the same size in stock." delay : 1h.Opening of a new ancillary instrument set and placement of a bigger nail.

• 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: 9703382
• Report Number: 0009610622-2020-00047
• Device Sequence Number: 19521952
• Product Code: HSB
• UDI-Device Identifier: 04546540197795
• UDI-Public: 04546540197795
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2020

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: 06/30/2024
• Device Model Number: 1822-0936S
• Device Catalogue Number: 18220936S
• Device Lot Number: K03F292
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2020
• Initial Date Received by Manufacturer: 01/16/2020
• Supplement Date Received by Manufacturer: 04/02/2020
• Initial Report FDA Received Date: 02/12/2020
• Supplement Report FDA Received Date: 04/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1