MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PHOENIX DRILL BIT; BIT, DRILL

Model Number	CAT02504
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)
Date of Event	12/18/2019
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 tip broke and a piece.Remains in the patient.
Event or Problem Description
It was reported that the tip broke and a piece 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: tip of drill broke off.Probable root cause: design - improper raw material selection.- insufficient assembly design.- hard stop not designed correctly.- guide mouth does not stabilize guide during drilling manufacturing.- improper assembly.- incorrect raw material used.- guide or drill not manufactured to specification application.- use of excessive force.The reported failure mode will be monitored for future reoccurrence.H3 other text : 81.

• Brand Name: PHOENIX DRILL BIT
• Common Device Name: BIT, DRILL
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 9570056
• Report Number: 0002936485-2020-00020
• Device Sequence Number: 16238752
• Product Code: HTW
• UDI-Device Identifier: 07613252633242
• UDI-Public: 07613252633242
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• 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): 02/25/2020

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: CAT02504
• Device Catalogue Number: CAT02504
• Device Lot Number: 17356AG2
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/18/2019
• Supplement Date Received by Manufacturer: 12/18/2019
• Initial Report FDA Received Date: 01/09/2020
• Supplement Report FDA Received Date: 02/26/2020
• 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: 44 YR