MAUDE Adverse Event Report: STRYKER SPINE-US SPECIALTY 4.5MM CANNULATED TAP; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	IS2210XLP
Medical Device Problem Codes	Fracture (1260); Material Integrity Problem (2978)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Known Impact Or Consequence To Patient (2692)
Date of Event	08/31/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the surgeon has become accustomed to using the speciality instrument and wants a replacement for the broken one.Update: distal tip of the tap broke off within patient vertebral body, the piece was left in the patient cavity.
Additional Manufacturer Narrative
Method: complaint history review; risk assessment; results: manufacturing records were not reviewed because no parts or lot number were provided.Per email correspondence with the sales rep, the awl was not used to prepare the pedicle prior to tapping.Conclusion: the probable root causes of this event are user error - awl not being used to prepare the pedicle.
Event or Problem Description
It was reported that the surgeon has become accustomed to using the speciality instrument and wants a replacement for the broken one.Update: distal tip of the tap broke off within patient vertebral body, the piece was left in the patient cavity.

• Brand Name: SPECIALTY 4.5MM CANNULATED TAP
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 5978374
• Report Number: 3004024955-2016-00088
• Device Sequence Number: 13469304
• Product Code: LXH
• UDI-Device Identifier: 07613327141900
• UDI-Public: (01)07613327141900
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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): 08/31/2016

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: IS2210XLP
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 08/31/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/26/2016
• Supplement Report FDA Received Date: 12/09/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1