MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG., WEDGE HS SUTURE ANCHOR II, 5.0MM; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number	3910-100-035
Medical Device Problem Code	Expiration Date Error (2528)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/19/2019
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 that an expired product was used.
Event or Problem Description
It was reported that an expired product was used.
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: use of expired product.Probable root cause: design, insufficient labeling design, insufficient shelf life validated, application, use past device/packaging shelf life.The reported failure mode will be monitored for future reoccurrence.

• Brand Name: PKG., WEDGE HS SUTURE ANCHOR II, 5.0MM
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 9766196
• Report Number: 0002936485-2020-00096
• Device Sequence Number: 526238
• Product Code: MBI
• UDI-Device Identifier: 37613154015307
• UDI-Public: 37613154015307
• Combination Product (Y/N): N
• Initial Reporter Country: ES
• PMA/510(K) Number: K041310
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2020

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 Catalogue Number: 3910-100-035
• Device Lot Number: 17191AE2
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/21/2020
• Supplement Date Received by Manufacturer: 02/21/2020
• Initial Report FDA Received Date: 02/27/2020
• Supplement Report FDA Received Date: 04/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1