MAUDE Adverse Event Report: STRYKER TRAUMA KIEL DRILL, TRI-FLAT, STERILE T2 TIBIA 4,2X260 MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	1806-4255S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/30/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon completion of the investigation any additional information will be communicated in a supplemental report.
Event or Problem Description
As reported: during surgery, the drill bit broke in contact with the nail inside the patient's bone.The tip of the drill bit has remained in the patient bone.The surgeon was trying to drill through the patient's bones, even though it was so hard.
Additional Manufacturer Narrative
The reported event could be confirmed, since the device was returned for evaluation and matches the reported failure mode.The device inspection revealed the following: the received drill bit shows signs of extensive and prolonged usage with its tip found to be broken.The remaining cutting edges show severe deformation.The breakage surface overall resembles a typical brittle fracture surface.However, significant permanent deformation was observed around the edges along the breakage surface.Most likely the drill was already blunt, which in turn required large amount of drilling force.Subsequently, due to a combination of high torsional and bending load, the drill broke off.The critical diameter of the drill was observed to be 4.168mm and average hardness of the drill was observed to be 56.3 hrc.As per the dimensional inspection and hardness testing, the returned drill was found to be within specifications.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 ifu clearly instructs the user: ¿stryker t&e typically does not specify the maximum number of uses appropriate for a reusable medical device.The useful life of these devices depends on many factors including the method and duration of each use, and the handling between uses.For a device that may be impacted check that the device is not damaged to the extent that it malfunctions or that burrs have been produced that could damage tissues or surgical gloves.Careful inspection and functional test of the device before use is the best method of determining the end of serviceable life for the medical device.¿ based on investigation, the root cause was attributed to a user related issue.The visual inspection suggested that the drill broke in a sudden manner.The breakage of the tip seems to be a forceful fracture while drilling it forcefully in a relatively harder bone.The device was manufactured in 2001, so it can be said that it has performed its function in the previous surgeries as intended without any reported failure.Since it has been long in use, thus a normal weakened structural integrity due to repeated reprocessing cycles is also possible.If any additional information is provided, the investigation will be reassessed.
Event or Problem Description
As reported: during surgery, the drill bit broke in contact with the nail inside the patient's bone.The tip of the drill bit has remained in the patient bone.The surgeon was trying to drill through the patient's bones, even though it was so hard.

• Brand Name: DRILL, TRI-FLAT, STERILE T2 TIBIA 4,2X260 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
• MDR Report Key: 11984861
• Report Number: 0009610622-2021-00557
• Device Sequence Number: 16953233
• Product Code: LXH
• UDI-Device Identifier: 04546540196750
• UDI-Public: 04546540196750
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2021

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: 06/30/2006
• Device Model Number: 1806-4255S
• Device Catalogue Number: 18064255S
• Device Lot Number: KBX008204
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2021
• Initial Date Received by Manufacturer: 05/31/2021
• Supplement Date Received by Manufacturer: 08/31/2021
• Initial Report FDA Received Date: 06/11/2021
• Supplement Report FDA Received Date: 09/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1