MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO L. MED AGGR BLADE (31MMX9MM)S; BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL

Catalog Number	2296003225
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/26/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow up report will be filed once the quality investigation is complete.Awaiting device return.
Event or Problem Description
It was reported that during a surgical procedure, the blade broke at the mount.It was also reported that there were no adverse consequences and no delays as a result of this event.It was further reported that the procedure was completed successfully.
Additional Manufacturer Narrative
Additional information: b5: updated procedure details.Device evaluation: d10 & h6: investigation results indicate that contact with metal during use, along with the application of a bending moment could have caused these blades to fail.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." the quality investigation is complete.
Event or Problem Description
It was reported that during a commmando surgical procedure, the blade broke at the mount.It was also reported that there were no adverse consequences and no delays as a result of this event.It was further reported that the procedure was completed successfully.

• Brand Name: L. MED AGGR BLADE (31MMX9MM)S
• 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: 9292101
• Report Number: 0001811755-2019-03686
• Device Sequence Number: 2172051
• Product Code: GFA
• UDI-Device Identifier: 04546540046550
• UDI-Public: 04546540046550
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: EXEMPT
• 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): 01/09/2020

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: 10/01/2021
• Device Catalogue Number: 2296003225
• Device Lot Number: 16284017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2019
• Initial Date Received by Manufacturer: 10/14/2019
• Supplement Date Received by Manufacturer: 01/09/2020
• Initial Report FDA Received Date: 11/07/2019
• Supplement Report FDA Received Date: 01/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1