MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO PRECISION THIN (7.0 X 0.38 X 18.5MM); BLADE, SAW, GENERAL & PLASTIC SURGERY,SURGICAL

Catalog Number	2296003114
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/24/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow up report will be filed once the quality investigation is complete.Awaiting return of device to manufacturer.
Event or Problem Description
It was reported that during a surgical procedure, the mount of the blade broke in three blades used.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.This record relates to one of the three blades which broke.
Additional Manufacturer Narrative
The reported blade reported involved with this event was returned for evaluation and the reported failure of breakage was confirmed.The device was sent to the product engineering group (r&d) who concluded that the bends present in the blade suggests that it was subjected to an excessive bending force or torque.This bending force / torque is the most likely cause of the reported mount break.The handpieces for use with this blade instructions for use(ifu) contain the following warning; "do not apply excessive pressure, such as bending or prying, with the blade.Excessive pressure may bend or fracture the blade and cause tissue damage and/or loss of tactile control.".
Event or Problem Description
It was reported that during a surgical procedure, the mount of the blade broke in three blades used.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.This record relates to one of the three blades which broke.

• Brand Name: PRECISION THIN (7.0 X 0.38 X 18.5MM)
• Common Device Name: BLADE, SAW, GENERAL & PLASTIC SURGERY,SURGICAL
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 8906127
• Report Number: 0001811755-2019-02722
• Device Sequence Number: 16781241
• Product Code: GFA
• UDI-Device Identifier: 04546540046505
• UDI-Public: 04546540046505
• Combination Product (Y/N): N
• Initial Reporter Country: SG
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2019

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: 06/01/2022
• Device Catalogue Number: 2296003114
• Device Lot Number: 17177027
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2019
• Initial Date Received by Manufacturer: 07/25/2019
• Supplement Date Received by Manufacturer: 09/20/2019
• Initial Report FDA Received Date: 08/19/2019
• Supplement Report FDA Received Date: 09/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1