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

Model Number	234-020-280
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	04/27/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information will be provided once the investigation has been completed.
Event or Problem Description
It was reported that the broken nitinol wire remains in the patient.
Event or Problem Description
It was reported that the broken nitinol wire remains in the patient.
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: 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
• Common Device Name: KIT, SURGICAL INSTRUMENT, DISPOSABLE
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 10071115
• Report Number: 0002936485-2020-00200
• Device Sequence Number: 2835133
• Product Code: KDD
• UDI-Device Identifier: 07613154643264
• UDI-Public: 07613154643264
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/07/2020

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
• Operator of Device: Health Professional
• Device Model Number: 234-020-280
• Device Catalogue Number: 0234020280
• Device Lot Number: 19178AG2
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/27/2020
• Supplement Date Received by Manufacturer: 04/27/2020
• Initial Report FDA Received Date: 05/19/2020
• Supplement Report FDA Received Date: 07/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 16 YR