MAUDE Adverse Event Report: STRYKER TRAUMA KIEL DRILL, AO SMALL GAMMA3 4.2 X 300 MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	1320-3042S
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	02/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device was not returned.If additional information becomes available, it will be provided in a supplemental report.Device disposition unknown.
Event or Problem Description
As reported in medwatch (b)(4): "the doctor was drilling for distal screw, noticed drill bit broke, was able to retrieve the tip but a small piece was left on the muscle as seen on x-ray and per doctor.".
Event or Problem Description
As reported in medwatch 2200350000-2020-8003: "the doctor was drilling for distal screw, noticed drill bit broke, was able to retrieve the tip but a small piece was left on the muscle as seen on x-ray and per doctor.".
Additional Manufacturer Narrative
The reported event could not be confirmed, since the device was not returned for evaluation and no other evidence was provided.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.Excerpts from the clinical assessment of a medical expert in a similar case: ¿an intra-operative breakage of a drill is a rare but common complication and well known to an experienced user.It is caused by twisting the drill and too much bending.Breakage caused by material defect is very rare in current manufacturing technology.It is of interest whether a broken part of a drill can be left in the bone or should be retrieved; also in the case that greater harm to the bone would be done.It is well known to an expert user that a broken part of a drill which is completely embedded in the bone normally does not cause any harm.Therefore, no further surgical procedures in this special case are required.¿ more information as well as the device must be available in order to determine the exact root cause.However, some of the possible causes could be, but not limited to: application of excessive bending and torsional forces.If the device is returned or if any additional information is provided, the investigation will be reassessed.

• Brand Name: DRILL, AO SMALL GAMMA3 4.2 X 300 MM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; DE D-24232
• MDR Report Key: 10299945
• Report Number: 0009610622-2020-00330
• Device Sequence Number: 667172
• Product Code: LXH
• UDI-Device Identifier: 04546540377890
• UDI-Public: 04546540377890
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• 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
• Report Date (Section B): 09/01/2020

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 Expiration Date: 07/31/2024
• Device Model Number: 1320-3042S
• Device Catalogue Number: 13203042S
• Device Lot Number: K0954C1
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/24/2020
• Supplement Date Received by Manufacturer: 08/06/2020
• Initial Report FDA Received Date: 07/20/2020
• Supplement Report FDA Received Date: 09/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 58 YR