MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE OMEGA 4.75MM PEEK KNOTLESS ANCHOR SYSTEM, DOUBLE-DOUBLE; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number 3910-500-472

Device Problems Material Fragmentation (1261); Device Slipped (1584)

Patient Problems Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/18/2020

Event Type  Injury  

Manufacturer Narrative

Additional information will be provided once the investigation has been completed.

Event Description

It was reported that the screw fell off of the inserter and remains in the patient.

Event Description

It was reported that the screw fell off of the inserter and remains in the patient.

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: omega screw fall off of the inserter and remained in the patient probable root cause: design - screw/driver interface not designed to maintain proper assembly - inadequate material selection process - screw or driver not manufactured to specification application - excessive force or leveraging of the screw against the bone the reported failure mode will be monitored for future reoccurrence.81.

• Brand Name: OMEGA 4.75MM PEEK KNOTLESS ANCHOR SYSTEM, DOUBLE-DOUBLE
• 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: 10671887
• MDR Text Key: 211255852
• Report Number: 0002936485-2020-00412
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 37613327464833
• UDI-Public: 37613327464833
• Combination Product (y/n): N
• PMA/PMN Number: K181083
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 12/16/2020

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: 3910-500-472
• Device Lot Number: 20021AG2
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/18/2020
• Initial Date FDA Received: 10/13/2020
• Supplement Dates Manufacturer Received: 09/18/2020
• Supplement Dates FDA Received: 12/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other