MAUDE Adverse Event Report: STRYKER SPINE-FRANCE ES2 CANNULATED MODULAR TAP; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	48280145
Medical Device Problem Codes	Fracture (1260); Material Integrity Problem (2978)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Information (3190)
Date of Event	05/23/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; tap 4.5 diameter damaged at tip.Jamshidi pedicle (l5) is punctures, immediate screw positioned 6.5mm diameter over k-wire.Did not work.Tap 5.5 diameter as preparation, did not succeed.Tap 4.5 diameter.Upon departure, tap in bone, check if tap in bone left through c-arch lateral projection.On rx, it was seen that the thread of the 4.5-diameter capped tap had come loose.
Event or Problem Description
It was reported that; tap 4.5 diameter damaged at tip.Jamshidi pedicle (l5) is punctures, immediate screw positioned 6.5mm diameter over k-wire.Did not work.Tap 5.5 diameter as preparation, did not succeed.Tap 4.5 diameter.Upon departure, tap in bone, check if tap in bone left through c-arch lateral projection.On rx, it was seen that the thread of the 4.5-diameter capped tap had come loose.

• Brand Name: ES2 CANNULATED MODULAR TAP
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 6652078
• Report Number: 0009617544-2017-00252
• Device Sequence Number: 2064470
• Product Code: LXH
• UDI-Device Identifier: 04546540710413
• UDI-Public: (01)04546540710413
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/25/2017

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: 48280145
• Device Lot Number: 151527
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2017
• Initial Date Received by Manufacturer: 05/24/2017
• Supplement Date Received by Manufacturer: 05/24/2017
• Initial Report FDA Received Date: 06/19/2017
• Supplement Report FDA Received Date: 08/25/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1