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 Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Foreign Body In Patient (2687)
Date of Event	05/31/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
The front part of a step drill (1320-0191) broke off during surgery at (b)(6).The broken-off part is still in the patient's bone.The procedure was delayed by 60 min.
Event or Problem Description
The front part of a step drill (1320-0191) broke off during surgery at (b)(6).The broken-off part is still in the patient's bone.The procedure was delayed by 60 min.
Additional Manufacturer Narrative
Please note correction to d9/h3 as the device was not returned for evaluation.Please also note corrections to h6 clinical signs codes.The reported event could be confirmed on provided x-ray.A device inspection was not possible since the affected device was not returned and no other physical evidences were provided for investigation.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.The tip of the stepdrill had completely broken off.Received x-ray showed the tip remained in the femur neck.The shaft fragment had not been returned for unknown reasons.Thus, a physical investigation was not possible.Manufacturing and inspection records revealed the unit had been delivered according to specs.Provided x-ray was presented to a medical expert regarding medical opinion.His comments: it is obvious that the removal of the tip fragment would potentially do a lot more harm, than leaving the fragment inside the body.1 hour is likely for a prolongation, as the surgeons may have tried to remove the broken fragment and it did take some time to place the lag screw in this very acceptable position.A normal patient without further severe chronic diseases should have no problems with the blood loss or the prolongation of the surgery for one hour.With available information product deficiency could not be verified; a real root cause could not be determined.If the device is returned or if any additional information is provided, the investigation will be reassessed.H3 other text : device disposition unknown.
Event or Problem Description
The front part of a step drill (1320-0191) broke off during surgery at uksh lübeck.The broken-off part is still in the patient's bone.The procedure was delayed by 60 min.
Additional Manufacturer Narrative
Please note the corrections to b1, b5 and h1type of reportable event.
Event or Problem Description
The front part of a step drill (1320-0191) broke off during surgery at (b)(6).The broken-off part is still in the patient's bone.The procedure was delayed by 60 min.It was further reported that the patient had a higher blood loss due to the surgical delay.

• 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: 14830633
• Report Number: 0009610622-2022-00312
• Device Sequence Number: 11358410
• Product Code: LXH
• UDI-Device Identifier: 04546540713421
• UDI-Public: 04546540713421
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1320-0191
• Device Catalogue Number: 13200191
• Device Lot Number: KU87905
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/02/2022
• Supplement Date Received by Manufacturer: 09/01/2022; 10/12/2022; 04/26/2023
• Initial Report FDA Received Date: 06/27/2022
• Supplement Report FDA Received Date: 09/27/2022; 11/07/2022; 05/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/27/2018
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male
• Patient Weight: 130 KG