MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE ACL DISPOSABLE PACK BONE-TENDON-BONE; KIT, SURGICAL INSTRUMENT, DISPOSABLE

Catalog Number	234-020-280
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/11/2020
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 that product was expired and used during the procedure.
Additional Manufacturer Narrative
This complaint investigation was closed based on the device not received, therefore the reported failure mode was not confirmed.In the event that the device is received, the complaint will be reopened and the investigation will be updated with new results.Alleged failure: expired product used.Probable root cause: design: validated shelf life too short.Application: distribution inefficient, sat too long in inventory before being shipped to customer.The reported failure mode will be monitored for future reoccurrence.
Event or Problem Description
It was reported that product was expired and used during the procedure.

• Brand Name: ACL DISPOSABLE PACK BONE-TENDON-BONE
• Common Device Name: KIT, SURGICAL INSTRUMENT, DISPOSABLE
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 10246701
• Report Number: 0002936485-2020-00262
• Device Sequence Number: 19033588
• Product Code: KDD
• UDI-Device Identifier: 37613154643265
• UDI-Public: 37613154643265
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 234-020-280
• Device Lot Number: 17363AG2
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/11/2020
• Supplement Date Received by Manufacturer: 06/11/2020
• Initial Report FDA Received Date: 07/08/2020
• Supplement Report FDA Received Date: 09/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 42 YR