MAUDE Adverse Event Report: STRYKER GMBH DRILL BIT Ø2.5X125MM AO FITTING; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	700347
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/19/2018
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
During acetabular impaction bone graft surgery, the drill bit broke and was left inside the patient when drilling 2nd screw hole.Since it was impossible to retrieve the broken drill bit, the surgery was continued with another drill bit.
Additional Manufacturer Narrative
The reported event that drill bit ø2.5x125mm ao fitting was alleged of 'breakage during surgery' could be confirmed.Based on investigation, the root cause was attributed to be user related.The failure was caused by too much force during drilling (possible inadequate angulation).The device inspection revealed the following: the tip of the returned drill bit is indeed completely broken / snapped off.Note that the cutting edges are blunt / damaged as well, which indicates that too much force had been applied (possible inadequate angulation during drilling) or that the drill was not in good working order.The close up views, done by the microscope, indicating though that the surface of the breakage is homogenous which again indicate conformity to the given specification (powerful dynamically overload during use).A review of the device history for the reported lot did not indicate any abnormalities.Note that a corrective action has already been initiated which is addressing such breakages.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If any further information is provided, the investigation report will be updated.
Event or Problem Description
During acetabular impaction bone graft surgery, the drill bit broke and was left inside the patient when drilling 2nd screw hole.Since it was impossible to retrieve the broken drill bit, the surgery was continued with another drill bit.

• Brand Name: DRILL BIT Ø2.5X125MM AO FITTING
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 7784905
• Report Number: 0008031020-2018-00554
• Device Sequence Number: 19211797
• Product Code: LXH
• UDI-Device Identifier: 04546540368973
• UDI-Public: 04546540368973
• 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): 09/20/2018

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: 700347
• Device Lot Number: 04455J
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2018
• Initial Date Received by Manufacturer: 07/19/2018
• Supplement Date Received by Manufacturer: 08/24/2018
• Initial Report FDA Received Date: 08/15/2018
• Supplement Report FDA Received Date: 09/20/2018
• 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