MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LOCKING SCREW, FULLY THREADED T2 TIBIA 5X55 MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	1896-5055S
Medical Device Problem Code	Failure to Align (2522)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/10/2020
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
As reported: "during the procedure, reduction of the femur fracture with a gamma ti nail, performed at the (b)(6) , when the implant was placed in the distal locking hole, the screw remained rolled, as it was not fixed to the bone or the nail, it was decided to change of implant and this second if it is fixed correctly.".
Additional Manufacturer Narrative
The reported event could not be confirmed, since the returned device is conforming to specifications and fully functional.In the case presented a 74-year-old female patient was treated with a gamma ti nail due to a femoral fracture.As per details provided the patient has poor bone quality and further, the use of bisphosphonates was reported.The device inspection revealed the following: visual inspection of the returned product was performed; the first three thread flanks at the tip of the returned locking screw are considerably flattened.Material abrasion was visible.Although damaged the screw was able to be screwed in and fixed within the sample bone; the reported event was not reproducible.Based on the above investigation, the root cause of the failure is related to a suboptimal intraoperative procedure [classic case of an oblique insertion - intraoperative misalignment - resulted in metal to metal contact] contributed by poor bone quality.As a result of this interaction which led to flattened threaded windings it could not be excluded that the reported ¿remained rolled¿ occurred due to impaired grip of threaded windings within poor bone quality.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.
Event or Problem Description
As reported: "during the procedure, reduction of the femur fracture with a gamma ti nail, performed at the león xiii clinic, when the implant was placed in the distal locking hole, the screw remained rolled, as it was not fixed to the bone or the nail, it was decided to change of implant and this second if it is fixed correctly.".

• Brand Name: LOCKING SCREW, FULLY THREADED T2 TIBIA 5X55 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; GM D-24232
• MDR Report Key: 11167974
• Report Number: 0009610622-2021-00229
• Device Sequence Number: 3532708
• Product Code: HSB
• UDI-Device Identifier: 04546540202529
• UDI-Public: 04546540202529
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K032244
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/26/2021

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 Expiration Date: 06/30/2025
• Device Model Number: 1896-5055S
• Device Catalogue Number: 18965055S
• Device Lot Number: K0E533B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2021
• Initial Date Received by Manufacturer: 12/17/2020
• Supplement Date Received by Manufacturer: 03/30/2021
• Initial Report FDA Received Date: 01/13/2021
• Supplement Report FDA Received Date: 04/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Weight: 68