MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO 2.0MM MTCH HD , 13CM; DRILLS, BURRS, TREPHINES & ACCESSORIES

Catalog Number	8450107020
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	05/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow up report will be filed once the quality investigation is complete.
Event or Problem Description
It was reported that on receipt of the blade, it was noted that the blade was broken.It was also reported that this event did not occur during a surgical procedure, and there was no patient involvement, no delay and no adverse consequences as a result of this event.
Event or Problem Description
It was reported that on receipt of the blade, it was noted that the blade was broken.It was also reported that this event did not occur during a surgical procedure, and there was no patient involvement, no delay and no adverse consequences as a result of this event.
Additional Manufacturer Narrative
The reported product involved with this event was returned for evaluation and the reported failure of breakage was confirmed.The device was sent to the product packaging design engineering who concluded that the evidence indicates of the observations of the product and packaging returned was that the package was crushed.This bent the pouch and tube resulting in the device breaking.The force required to bend the tube is far in excess of that expected during distribution.This force may have been as a result of a heavier device (such as a handpiece) being packed on top of this product, or mis-handling during the distribution process.The quality investigation is complete.

• Brand Name: 2.0MM MTCH HD , 13CM
• Common Device Name: DRILLS, BURRS, TREPHINES & ACCESSORIES
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 8703427
• Report Number: 0001811755-2019-02046
• Device Sequence Number: 16605408
• Product Code: HBE
• UDI-Device Identifier: 07613327096989
• UDI-Public: 07613327096989
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K143540
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/04/2019

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 Expiration Date: 01/01/2022
• Device Catalogue Number: 8450107020
• Device Lot Number: 19011017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2019
• Initial Date Received by Manufacturer: 05/20/2019
• Supplement Date Received by Manufacturer: 08/26/2019
• Initial Report FDA Received Date: 06/17/2019
• Supplement Report FDA Received Date: 09/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1