MAUDE Adverse Event Report: STRYKER SPINE-FRANCE ESCALATE DRILL BIT; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT.

Catalog Number	48570118
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Code Available (3191)
Date of Event	03/03/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery, an 8mm drill bit was used to prepare a screw.While drilling, the drill bit tip broke off and was left in the bone.
Additional Manufacturer Narrative
Method: visual inspection; functional inspection; device history review; complaint history review; risk assessment.Results: manufacturing records were reviewed and the instrument and no anomalies were found.Material analysis was performed and found no material or manufacturing defects.The stryker rep reported that these were used approximately 12 times and the patient had normal bone quality.Conclusion: the probable root cause is not determined and multifactorial.
Event or Problem Description
It was reported that during surgery, an 8mm drill bit was used to prepare a screw.While drilling, the drill bit tip broke off and was left in the bone.

• Brand Name: ESCALATE DRILL BIT
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT.
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 5517420
• Report Number: 0009617544-2016-00131
• Device Sequence Number: 16428024
• Product Code: LXH
• UDI-Device Identifier: 07613327271904
• UDI-Public: (01)07613327271904
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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): 03/03/2016

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: No Information
• Device Catalogue Number: 48570118
• Device Lot Number: 141823
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/03/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/22/2016
• Supplement Report FDA Received Date: 06/10/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1