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

Model Number 234-020-280

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 04/27/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that the broken nitinol wire remains in the patient.

Event Description

It was reported that the broken nitinol wire 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: broken nitinol wire.Probable root cause: design: inadequate instrument design for usage process.Instrument manufactured out of specification.Instrument not assembled properly application.User not applying forces correctly on instrument.User applying excessive force on instrument.Use past expected device lifetime.The reported failure mode will be monitored for future reoccurrence.

• Brand Name: ACL DISPOSABLE PACK BONE-TENDON-BONE
• Type of Device: KIT, SURGICAL INSTRUMENT, DISPOSABLE
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 10071115
• MDR Text Key: 191524485
• Report Number: 0002936485-2020-00200
• Device Sequence Number: 1
• Product Code: KDD
• UDI-Device Identifier: 07613154643264
• UDI-Public: 07613154643264
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 07/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 234-020-280
• Device Catalogue Number: 0234020280
• Device Lot Number: 19178AG2
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 16 YR