MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE HD 4MM X 0° ARTHROSCOPE SPEEDLOCK A/C

Catalog Number	0502104010
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/23/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information will be provided once the investigation has been completed.
Event or Problem Description
It was reported the distal tip of the scope chipped during surgery.All pieces were retrieved.
Additional Manufacturer Narrative
Alleged failure: per rep, distal tip chip on scope.Rep said it was surgeons 1st time use with arthroscope.Rma 12102667 salesforce case number (b)(4).The failure(s) identified in the investigation is consistent with the complaint record.The probable root cause/s could be contact with a cutter or burr during activation, and/or improper sterilization and/or reprocessing methods.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.
Event or Problem Description
It was reported the distal tip of the scope chipped during surgery.All pieces were retrieved.

• Brand Name: HD 4MM X 0° ARTHROSCOPE SPEEDLOCK A/C
• Common Device Name: ARTHROSCOPE
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 9070691
• Report Number: 0002936485-2019-00393
• Device Sequence Number: 2550871
• Product Code: HRX
• UDI-Device Identifier: 07613327062137
• UDI-Public: 07613327062137
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K962075
• 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): 12/06/2019

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 Catalogue Number: 0502104010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2019
• Initial Date Received by Manufacturer: 08/23/2019
• Supplement Date Received by Manufacturer: 08/23/2019
• Initial Report FDA Received Date: 09/16/2019
• Supplement Report FDA Received Date: 12/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1