MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PACKAGING, FORMULA SHAVER (HAND CONTROL); BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL

Model Number	0375704500
Medical Device Problem Code	Insufficient Cooling (1130)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/21/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information will be provided once the investigation has been completed.The device manufacturer date is not known at this time.However, should it become available it will be provided in future reports.
Event or Problem Description
It was reported that the device became hot during use.
Additional Manufacturer Narrative
Alleged failure: i have another shaver hand piece that is defective at surg ctr- acct#: (b)(4), (b)(6) center and am hoping we can ship them a replacement.The device began to get hot and make a clicking noise again just like the others.The ones we have replaced have not had any issues which makes me believe it was a bad lot sent in.Below is the serial number on the defective handpiece.Additionally, they had a foot pedal that went down and has stopped working.Outside body looks fine, however i tested and plugged into a console and it does not work.These items should both be covered under warranty.Handpiece pn: 0375704500, sn: (b)(6).The failure alleged in the complaint record was not confirmed/duplicated during the product investigation.The probable root causes could be 1) excessive force applied to the cutter/burr by the user with poor or no suction during use.(excessive force may cause friction due to bur shaft assembly and housing assembly interaction.) (2) tissue blocking the suction pathway would prevent hot fluid from being removed from the joint.(3) poor arthroscopy pump suction.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.
Event or Problem Description
It was reported that the device became hot during use.

• Brand Name: PACKAGING, FORMULA SHAVER (HAND CONTROL)
• Common Device Name: BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 11346551
• Report Number: 0002936485-2021-00099
• Device Sequence Number: 17153172
• Product Code: GFA
• UDI-Device Identifier: 07613327057638
• UDI-Public: 07613327057638
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• 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): 04/11/2021

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 Model Number: 0375704500
• Device Catalogue Number: 0375704500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2021
• Initial Date Received by Manufacturer: 01/21/2021
• Supplement Date Received by Manufacturer: 01/21/2021
• Initial Report FDA Received Date: 02/18/2021
• Supplement Report FDA Received Date: 04/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1