MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LAG SCREW STEP DRILL GAMMA3® Ø10.5X495 MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	1320-0191
Medical Device Problem Code	Device Difficult to Setup or Prepare (1487)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/10/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.Should additional information become available, it will be provided in a supplemental report.
Event or Problem Description
It was reported that the device was not passing through.
Event or Problem Description
It was reported that the device was not passing through.
Additional Manufacturer Narrative
Please note corrections to d9/h3 as the device was returned for evaluation.Please also note the corrections to h6 clinical and h6 health impact codes.The reported event could be confirmed, since the device was returned for evaluation and matches the alleged failure mode.The tips of the step drill were deformed in terms of being bent inside reducing the diameter.The threads of the k-wire passed this narrow diameter but the full shaft diameter was not accepted.Significantly damaged, resp.Notched, cutting edges were caused by contact with the edges of the nail's proximal drill hole.Such an event would also damage the tips - or the item was simply dropped on the floor which also would deform the tips as found.Manufacturing and inspection records revealed the unit had been delivered according to specs.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.With the available information and the above investigation, a product deficiency could not be verified.The root cause was concluded being user related.

• Brand Name: LAG SCREW STEP DRILL GAMMA3® Ø10.5X495 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: 14852484
• Report Number: 0009610622-2022-00314
• Device Sequence Number: 11970146
• Product Code: LXH
• UDI-Device Identifier: 04546540713421
• UDI-Public: 04546540713421
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 11/15/2022

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: 1320-0191
• Device Catalogue Number: 13200191
• Device Lot Number: KU67590
• 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: 06/10/2022
• Supplement Date Received by Manufacturer: 10/18/2022
• Initial Report FDA Received Date: 06/29/2022
• Supplement Report FDA Received Date: 11/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/13/2016
• 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