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	09/21/2021
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 during a case using a t2 tibial nail the nail holding screw [pn 1806-1401] was jammed in the nail adaptor [pn 1806-1402].We switched from suprapatellar to infrapatellar.A second incision has to be made and 20min delay in surgical time.
Event or Problem Description
It was reported that during a case using a t2 tibial nail the nail holding screw [pn 1806-1401] was jammed in the nail adaptor [pn 1806-1402].We switched from suprapatellar to infrapatellar.A second incision has to be made and 20min delay in surgical time.
Additional Manufacturer Narrative
Please note correction to section b1 and b2.The reportability decision was revised to malfunction after completion of the investigation.Indeed, the investigation revealed a severity level of s2.According to our procedure an s2 severity level is not considered as serious injury.The reported event could be confirmed, since the devices are in the received condition not functional anymore.The device inspection revealed the following: the devices were returned in disassembled condition.The hexagon of the holding screw is strongly damaged, which was most likely caused during the forcible removal of the screw.Significant fretting marks running over the whole circumference were visible on the outer surface of the shaft of the nail holding screw (nhs) close to the beginning of the thread.In addition there is a strong deformation at the forefront visible, the deformation was most likely caused by a hit with another instrument.However, afterwards it cannot be defined if this damage occurred before or after the complained malfunction.The functional test has shown that it is not possible to fully insert the nail holding screw into the adapter anymore.The insertion of the holding screw stops at the pins at the forefront of the adapter.The relevant dimensions of the device were verified during the evaluation and no deviation from the specification could be detected.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.No indications of material, manufacturing or design related problems were found during the investigation.Based on investigation, the root cause was attributed to a user related issue.The appearance of damage indicates that the devices got jammed by ¿cold welding¿ due to friction welding being caused by high surface pressure.Local surface pressure may arise when the items are assembled under misalignment.If more information is provided, the case will be reassessed.

• 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: 12614178
• Report Number: 0009610622-2021-00756
• Device Sequence Number: 1335091
• 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): 12/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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
• Date Returned to Manufacturer: 10/13/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/21/2021
• Supplement Date Received by Manufacturer: 12/16/2021
• Initial Report FDA Received Date: 10/12/2021
• Supplement Report FDA Received Date: 12/30/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/29/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown