MAUDE Adverse Event Report: STRYKER GMBH CENTERING DRILL; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	5901-0025
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	04/22/2019
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
It was reported that, during a primary procedure on a right shoulder, the tip of the centering drill broke off in the patient when drilling through the centering guide.Piece was removed from patient.Surgery was completed successfully with a surgical delay of under one minute.
Event or Problem Description
It was reported that, during a primary procedure on a right shoulder, the tip of the centering drill broke off in the patient when drilling through the centering guide.Piece was removed from patient.Surgery was completed successfully with a surgical delay of under one minute.
Additional Manufacturer Narrative
The reported event could be confirmed.During investigation, the device inspection revealed the following: the tip of the device at the level of the threaded area is indeed broken.A microscope inspection shows the particularities of a fatigue fracture with multiple origins and ratchet marks.Indeed, on the outskirts of the breakage surface, the metal has shiny areas which prove that the cracks started from there, before progressing towards the center of the drill.The surface of the metal at the center has a coarse grained texture, which proves that the device broke instantaneously and completely at that point.Based on this analysis, the root cause of the event could be attributed to the fatigue of the material, generated by the normal wear of the device.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: CENTERING DRILL
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 8601876
• Report Number: 0008031020-2019-00454
• Device Sequence Number: 2281007
• Product Code: LXH
• UDI-Device Identifier: 07613327099300
• UDI-Public: 07613327099300
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 08/06/2019

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: 5901-0025
• Device Lot Number: SC6K04
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2019
• Initial Date Received by Manufacturer: 04/22/2019
• Supplement Date Received by Manufacturer: 07/11/2019
• Initial Report FDA Received Date: 05/10/2019
• Supplement Report FDA Received Date: 08/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 62 YR