MAUDE Adverse Event Report: STRYKER TRAUMA KIEL TARGETING ARM TNS T2 TIBIA; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	1806-1001
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/20/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported event could be confirmed, since the device was returned for evaluation and matches the alleged failure mode.Device inspection revealed the following: the returned targeting arm shows several signs of usage.The adhesive binding is loose at both glued edge joint of the right outer portion of the device, in this area the connection has play i,e wobbles slightly.Entry point of the sleeve at the right down portion of the device shows slight deformation and visibility of cracks along the adjoining edges.A review of the device history for the reported lot did not indicate any abnormalities.No indications of manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.Based on the above investigation, the root cause was attributed to user related issue.Appearance of deformation around the sleeve hole indicates towards an unintended high insertion force in a non-axial direction, leading to cracking of the adjoining edge.It is also likely that due to long and repeated usage, natural weakening of structural integrity is also possible.If any additional information is provided, the investigation will be reassessed.
Event or Problem Description
It was reported the tibia nail distal targeting device has been broken where the text m-l holes for standard or distal nail only is found.This was noticed when the surgeon was putting in the screws; it was lacking a few mm to correctly have them fit into the nail.The operation was completed without any problems for the patient by setting screws in the nail using another screw hole.There was no clinically significant delay in treatment.

• Brand Name: TARGETING ARM TNS T2 TIBIA
• 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
• MDR Report Key: 12196994
• Report Number: 0009610622-2021-00613
• Device Sequence Number: 11612388
• Product Code: LXH
• UDI-Device Identifier: 04546540196521
• UDI-Public: 04546540196521
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 07/20/2021

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: 1806-1001
• Device Catalogue Number: 18061001
• Device Lot Number: KHI030608
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/25/2021
• Initial Report FDA Received Date: 07/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1