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

Model Number 1320-0191

Device Problem Device Difficult to Setup or Prepare (1487)

Patient Problem Insufficient Information (4580)

Event Date 06/10/2022

Event Type  malfunction  

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 Description

It was reported that the device was not passing through.

Event Description

It was reported that the device was not passing through.

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
• Type of Device: 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
• MDR Text Key: 302497243
• Report Number: 0009610622-2022-00314
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 04546540713421
• UDI-Public: 04546540713421
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 06/10/2022
• Initial Date FDA Received: 06/29/2022
• Supplement Dates Manufacturer Received: 10/18/2022
• Supplement Dates FDA Received: 11/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/13/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1