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

Catalog Number	48280145
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Code Available (3191)
Date of Event	06/22/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; treated for t12 fracture, it was performed to fix the t11, t12, l1, l2.For l2 right pedicle, the needle could not be inserted because the bone were hard.So hit the bone by hammer, however it could not insert it from the way.Then attempted to insert using the tap of the smallest size, but the tap was broken.Tip of broken tap was removed out of patient body.Finnally, it was completed the procedure without implanting the screw for l2.
Additional Manufacturer Narrative
Method: visual inspection, device history review, complaint history review, risk assessment; result: the customer reported event of tap tip fracture was confirmed via visual inspection.No relevant manufacturing issues were identified as all units met stryker specifications.Conclusion: the plausible root cause of the event is not using awl to prepare the hole in the pedicle and hard bone quality leading to application of additional force during tapping.
Event or Problem Description
It was reported that; treated for t12 fracture, it was performed to fix the t11¿t12¿l1¿l2.For l2 right pedicle, the needle could not be inserted because the bone were hard.So hit the bone by hammer, however it could not insert it from the way.Then attempted to insert using the tap of the smallest size, but the tap was broken.Tip of broken tap was removed out of patient body.Finally, it was completed the procedure without implanting the screw for l2.

• 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: 6720062
• Report Number: 0009617544-2017-00286
• Device Sequence Number: 1464971
• Product Code: LXH
• UDI-Device Identifier: 04546540710413
• UDI-Public: (01)04546540710413
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/27/2017

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: 153234
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2017
• Initial Date Received by Manufacturer: 06/22/2017
• Supplement Date Received by Manufacturer: 06/22/2017
• Initial Report FDA Received Date: 07/17/2017
• Supplement Report FDA Received Date: 09/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 30 YR
• Patient Weight: 70