MAUDE Adverse Event Report: STRYKER TRAUMA KIEL DRILL, TRI-FLAT T2 TIBIA Ø3,5X130 MM; SURGICAL INSTRUMENT MOTORS AND ACCESSORIES/ATTACHMENTS

Catalog Number	18063555
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/22/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
It was reported that when drilling was done with free hand technique during surgery with t2h, the tip of the drill was broken and left in the bone.Therefore, drilled a hole with crown reamer from the other side and the broken part was removed.The doctor's opinion: when he drilled, he put too much angle and it was broken.
Additional Manufacturer Narrative
The reported event that drill, tri-flat t2 tibia ø3,5x130 mm was alleged of issue k-275-a (instruments - drill - broken) could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.The device inspection was not possible as the product was not returned for investigation.The device history record could not be reviewed because the affected device was not returned and the lot number was not communicated.A review of the labeling did not indicate any abnormalities.If device is returned or any further information is provided, the investigation report will be reassessed.Device disposition unknown.
Event or Problem Description
It was reported that when drilling was done with free hand technique during surgery with t2h, the tip of the drill was broken and left in the bone.Therefore, drilled a hole with crown reamer from the other side and the broken part was removed.The doctor's opinion: when he drilled, he put too much angle and it was broken.

• Brand Name: DRILL, TRI-FLAT T2 TIBIA Ø3,5X130 MM
• Common Device Name: SURGICAL INSTRUMENT MOTORS AND ACCESSORIES/ATTACHMENTS
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32
• MDR Report Key: 8075004
• Report Number: 0009610622-2018-01383
• Device Sequence Number: 16616184
• Product Code: HWE
• UDI-Device Identifier: 04546540196668
• UDI-Public: 04546540196668
• Combination Product (Y/N): N
• 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): 01/25/2019

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 Catalogue Number: 18063555
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/22/2018
• Supplement Date Received by Manufacturer: 12/28/2018
• Initial Report FDA Received Date: 11/15/2018
• Supplement Report FDA Received Date: 01/25/2019
• 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