MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE ASSY., PKG TWINLOOP FLEX DRILL; BIT, DRILL

Catalog Number	3910-400-100
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/16/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information will be provided once the investigation has been completed.
Event or Problem Description
It was reported that the tip of the drill broke during the procedure.The tip was retrieved.
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: drill broke.Probable root cause: design.Drill design too weak.Drill material too weak.Manufacturing processes selected weaken drill material.Drill extends too far beyond guide.Process.Drill manufactured out of specification.Application.Excessive force while drilling.Selection of wrong drill.Reuse of disposable drill.Use of reusable drill past lifetime.Starting and stopping drill.Pulling drill out of bone without running drill.Moving drill guide during drilling.The reported failure mode will be monitored for future reoccurrence.H3 other text : 81.
Event or Problem Description
It was reported that the tip of the drill broke during the procedure.The tip was retrieved.

• Brand Name: ASSY., PKG TWINLOOP FLEX DRILL
• Common Device Name: BIT, DRILL
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 11016233
• Report Number: 0002936485-2020-00530
• Device Sequence Number: 10944716
• Product Code: HTW
• UDI-Device Identifier: 34546540678226
• UDI-Public: 34546540678226
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 3910-400-100
• Device Lot Number: 20170AG2
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/19/2020
• Supplement Date Received by Manufacturer: 11/19/2020
• Initial Report FDA Received Date: 12/16/2020
• Supplement Report FDA Received Date: 02/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 29 YR