MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO 3.0MM PRCSN MTCH HD, 13CM; DRILLS, BURRS, TREPHINES & ACCESSORIES

Catalog Number	8450107530
Medical Device Problem Code	Expiration Date Error (2528)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/24/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow up report will be filed once the quality investigation is complete.Device discarded by customer.
Event or Problem Description
It was reported that during a surgical procedure, the surgeon used an expired bur.It was also reported there were no delays and no adverse consequences as a result of this event.It was further reported that the procedure was completed successfully.
Event or Problem Description
It was reported that during a surgical procedure, the surgeon used an expired bur.It was also reported there were no delays and no adverse consequences as a result of this event.It was further reported that the procedure was completed successfully.
Additional Manufacturer Narrative
The bur reported involved in this event was not returned for evaluation.It was reported in this case that the surgeon acknowledged use of an expired bur and wanted to enquire into the risk associated with using an expired product.There is no reported malfunction of a stryker product evident in this case.Photo evidence of the bur product label was provided where it was observed that the bur was expired.Stryker instruments applies a three (03) year expiry date on product catalog number 8450-107-525 2.5mm prcsn mtch hd, 13cm and is provided as a sterile product.The expiration date is indicated on the product label and is expressed as a four-digit year followed by a two-digit month and a two-digit day.Preceding this expiration date information is a partially filled hourglass symbol identifier symbolizing use-by date, which is a harmonized symbol per the relevant labeling standard.The associated expanded content label #0036-894-000 rev.A contains this symbol definition.While the expiration period for catalog number 8450-107-525 2.5mm prcsn mtch hd, 13cm is labeled for a three (03) year expiration the product packaging sterile barrier integrity has been tested for five (05) years.Stryker are not medical professionals and cannot make decisions concerning the health and welfare of patients where an expired product may have been used during a surgical procedure.The treating physician is the only individual that can make decisions for his/her patient.Product beyond its expiry date must not be used as its safety and effectiveness cannot be predicted.

• Brand Name: 3.0MM PRCSN 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: 8696360
• Report Number: 0001811755-2019-02012
• Device Sequence Number: 2246979
• Product Code: HBE
• UDI-Device Identifier: 07613327097016
• UDI-Public: 07613327097016
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K143540
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2019

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: 12/01/2018
• Device Catalogue Number: 8450107530
• Device Lot Number: 15338017
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/15/2019
• Supplement Date Received by Manufacturer: 08/23/2019
• Initial Report FDA Received Date: 06/13/2019
• Supplement Report FDA Received Date: 08/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1