MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE UNKNOWN_ENDOSCOPY_PRODUCT; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number UNK_END

Device Problems Device Dislodged or Dislocated (2923); Positioning Problem (3009)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/15/2019

Event Type  Injury  

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.The part number is unknown, therefore the gtin and 510k are not known at this time.However, should it become available it will be provided in future reports.

Event Description

It was reported that the anchor pulled out of the bone post-op.

Manufacturer Narrative

The product was not returned for investigation therefore the reported failure mode was not confirmed.Alleged failure: anchor pulled out probable root cause: design - insufficient material strength - insufficient design geometry - tether suture too weak for application process - tab not manufactured to specification - tether suture not manufactured to specification application - excessive force the failure mode will be monitored for future reoccurrence.Lot number is unknown; therefore, manufacture date cannot be confirmed.Part number is unknown; therefore, gtin cannot be confirmed.

Event Description

It was reported that the anchor pulled out of the bone post-op.

• Brand Name: UNKNOWN_ENDOSCOPY_PRODUCT
• Type of Device: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 9305876
• MDR Text Key: 165962431
• Report Number: 0002936485-2019-00502
• Device Sequence Number: 1
• Product Code: MBI
• Combination Product (y/n): N
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 02/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK_END
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/15/2019
• Initial Date FDA Received: 11/11/2019
• Supplement Dates Manufacturer Received: 10/15/2019
• Supplement Dates FDA Received: 02/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other