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 Known Impact Or Consequence To Patient (2692)
Date of Event	11/20/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow up report will be filed once the quality investigation is complete.No information available on device return.
Event or Problem Description
It was reported that during a surgical procedure, two saw blades broke.It was also reported that the blade was mounted on the stryker core motor handpiece.No further information was provided.This mdr is related to the second blade that broke.
Additional Manufacturer Narrative
Investigation results indicate that the bend present in the blade suggests that it was subjected to an excessive bending force.This bending force is the most likely cause of the mount break.The bending forces could of occurred by pushing the handpiece forward, or pulling it backwards or twisting the handpiece while the end of the blade was engaged or held.The ifu of handpieces associated with this device warn the user against this type of use: "do not apply excessive pressure, such as bending or prying, with the cutting accessory.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, two saw blades broke.It was also reported that the blade was mounted on the stryker core motor handpiece.No further information was provided.This mdr is related to the second blade that 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: 8261737
• Report Number: 0001811755-2019-00173
• Device Sequence Number: 19253983
• Product Code: GFA
• UDI-Device Identifier: 04546540046505
• UDI-Public: 04546540046505
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 05/21/2019

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: 04/01/2023
• Device Catalogue Number: 2296003114
• Device Lot Number: 18113037
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2019
• Initial Date Received by Manufacturer: 01/16/2019
• Supplement Date Received by Manufacturer: 05/21/2019
• Initial Report FDA Received Date: 01/18/2019
• Supplement Report FDA Received Date: 05/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 6400034000E SN(B)(4)