MAUDE Adverse Event Report: STRYKER TRAUMA KIEL TISSUE PROTECTION SLEEVE, SHORT T2 TIBIA Ø9 MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	1806-0180
Medical Device Problem Codes	Material Deformation (2976); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/16/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided on a supplemental report.Device disposition unknown.
Event or Problem Description
As reported: "during revision surgery, mistarget was occurred with the target device at 1st and 4th screwholes from proximal.Also, the drill sleeve became stuck in the guide sleeve, and when it was forcibly pulled out with pliers, the threads of the guide sleeve were crushed.".
Event or Problem Description
As reported: "during revision surgery, mistarget was occurred with the target device at 1st and 4th screwholes from proximal.Also, the drill sleeve became stuck in the guide sleeve, and when it was forcibly pulled out with pliers, the threads of the guide sleeve were crushed.".
Additional Manufacturer Narrative
Please note the corrections to d9/h3, method, results and conclusion codes as the device was returned for evaluation.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 received sleeve shows normal signs of usage, evident by scratch marks over its outer surface.However, significant damage was observed on the initial two internal threads of the sleeve.The deformation could be seen on 4 different sides of the threads in the upward direction as if a square-shaped tool was inserted and pulled up.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing, or design-related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.Based on the investigation and the nature of deformation, the issue is user-related.However, the exact root cause of the deformation could not be determined.It is highly likely that the threads were deformed before the surgery itself as engagement of it with a drill sleeve cannot lead to such a deformation.If any further information is provided, the complaint report will be updated.

• Brand Name: TISSUE PROTECTION SLEEVE, SHORT T2 TIBIA Ø9 MM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• 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: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 14107999
• Report Number: 0009610622-2022-00134
• Device Sequence Number: 6370388
• Product Code: LXH
• UDI-Device Identifier: 04546540196132
• UDI-Public: 04546540196132
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 08/03/2022

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: 1806-0180
• Device Catalogue Number: 18060180
• Device Lot Number: K0AF1EB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/16/2022
• Supplement Date Received by Manufacturer: 07/05/2022
• Initial Report FDA Received Date: 04/13/2022
• Supplement Report FDA Received Date: 08/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2015
• 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