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

Model Number	700347
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/09/2020
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
As reported: "use rim mesh for acetabular.It breaks when using a drill to fix the mesh.The thin and hard bone and the long drilling may have made it more fragile.".
Additional Manufacturer Narrative
The reported event could be confirmed.The device inspection revealed the following: the tip of the returned drill bit is indeed completely broken / snapped off.The cutting edges are blunt / worn / damaged as well, which indicates that this device has been in good use over the years (manufactured in may 2013).Possibly too much force had been applied (inadequate angulation during drilling) or that the drill was not in good working order, which has finally led to the tip breakage.The root cause of the final breakage can be determined to be due to repetitive use over the years (wear and tear).The device as such is worn (faded color).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.No indications of material, manufacturing or design related problems were found during the investigation.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).If any further information is provided, the investigation report will be updated.
Event or Problem Description
As reported: "use rim mesh for acetabular.It breaks when using a drill to fix the mesh.The thin and hard bone and the long drilling may have made it more fragile.".

• 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: 9674148
• Report Number: 0008031020-2020-00314
• Device Sequence Number: 2791184
• 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): 03/16/2020

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 Model Number: 700347
• Device Catalogue Number: 700347
• Device Lot Number: 00333R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2020
• Initial Date Received by Manufacturer: 01/09/2020
• Supplement Date Received by Manufacturer: 02/18/2020
• Initial Report FDA Received Date: 02/05/2020
• Supplement Report FDA Received Date: 03/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1