MAUDE Adverse Event Report: STRYKER TRAUMA KIEL NAIL HOLDING SCREW T2 TIBIA SPI; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	1806-1401
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/02/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon completion of the investigation, additional information will be provided in a supplemental report.
Event or Problem Description
It was reported that during implantation of a t2 tibial nail using the suprapatellar instrumentation the nail appeared to have gotten fused to the nail holding bolt and insertion arm.The staff spent 10-15 minutes attempting to disengage the nail but were unable to.They elected to use the standard approach with a new nail.The nail was able to be disengaged after it was returned to stryker (b)(4).
Event or Problem Description
It was reported that during implantation of a t2 tibial nail using the suprapatellar instrumentation the nail appeared to have gotten fused to the nail holding bolt and insertion arm.The staff spent 10-15 minutes attempting to disengage the nail but were unable to.They elected to use the standard approach with a new nail.The nail was able to be disengaged after it was returned to stryker canada.
Additional Manufacturer Narrative
The reported event could be confirmed, since the product was returned for evaluation and matches the alleged failure mode.The device inspection revealed the following: the devices were returned in a disassembled state.Significant fretting marks are visible running along the outer circumference near the nail holding screw thread.The hexagonal screw head is heavily damaged indicating exposure to substantial hammering.During functional test, it can be observed that it is not possible to fully insert nail holding screw in the targeting arm sleeve slight resistance can be observed.Since both the targeting arm and nail holding screw have fretting marks it is possible that device got jammed by frictional welding.No indications of material, manufacturing or design related problems were found during the investigation.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.The instructions for use instructs user that: ¿ensure that you are familiar with the intended uses, indications/contraindications, compatibility and correct handling of the implant, which are described in the operative technique manual for the product system.Please remember that product systems may be subject to alterations that affect the compatibility of the implant with other implants or with instruments¿.Based on investigation, the root cause was attributed to a user related issue.The appearance of damage indicates that the devices were cold welded due to high surface pressure caused by assembly under misalignment.If any further information is provided, the complaint report will be updated.

• Brand Name: NAIL HOLDING SCREW T2 TIBIA SPI
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer Contact: marilyne chaumont ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 12785968
• Report Number: 0009610622-2021-00781
• Device Sequence Number: 3808000
• Product Code: HSB
• UDI-Device Identifier: 07613327005394
• UDI-Public: 07613327005394
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K131365
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/12/2022

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 Model Number: 1806-1401
• Device Catalogue Number: 18061401
• Device Lot Number: K03CD8C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/13/2021
• Supplement Date Received by Manufacturer: 03/15/2022
• Initial Report FDA Received Date: 11/10/2021
• Supplement Report FDA Received Date: 04/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/28/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown