MAUDE Adverse Event Report: STRYKER GMBH PEG/KEEL DRILL; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	5901-0028
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
Event or Problem Description
As reported: "while drilling the inferior/posterior hole, for preparation of a pegged glenoid implant during a reunion tsa procedure, the tip of the peg/keel drill (5901-0028) got bound into the drill hole of the pegged drill guide (5901-1026l) which in turn resulted in the tip of the peg/keel drill (5901-0028) to break off.The second peg/keel drill (5901-0028) that is provided in the instrument set was used without difficulties.".
Additional Manufacturer Narrative
The reported event could be confirmed.The device inspection revealed the following: the device is broken at the level of the drilled part.A microscope analysis shows plastic deformation on the outskirts of the broken surface.Typically, fractures due to normal wear of the device start with plastic deformations on the surface of the drill, which generate cracks that propagate in the material before breaking completely.This case is an example of such a fracture.As a conclusion, normal wear of the device can be considered to be the root cause of the event reported.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.If any further information is provided, the investigation report will be updated.

• Brand Name: PEG/KEEL DRILL
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 10209178
• Report Number: 0008031020-2020-01810
• Device Sequence Number: 2095355
• Product Code: LXH
• UDI-Device Identifier: 07613327099225
• UDI-Public: 07613327099225
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• 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): 08/05/2020

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: 5901-0028
• Device Catalogue Number: 5901-0028
• Device Lot Number: SC17885
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2020
• Initial Date Received by Manufacturer: 06/03/2020
• Supplement Date Received by Manufacturer: 07/09/2020
• Initial Report FDA Received Date: 06/29/2020
• Supplement Report FDA Received Date: 08/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1