MAUDE Adverse Event Report: DEPUY SYNTHES SPINE MOD 5MM TAP; UNKNOWN

Catalog Number	698331539
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Blood Loss (2597); Not Applicable (3189)
Date of Event	11/07/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Device is available for evaluation.Investigation will be conducted.Follow up will be filed with investigation results.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported surgeon was tapping the left l5 pedicle when the tap broke off in the pedicle.Both pieces of the tap were able to be retrieved.Later in the case, surgeon sheared the tip off of a driver while inserting the right l5 screw.Surgeon tried to remove screw by helicoptering it out.While doing this, the head sheared from the screw shank.Both were removed.Surgeon inserted a larger diameter screw at the same level and another driver tip sheared.Two and half hour delay and blood loss was reported.
Additional Manufacturer Narrative
Product complaint # (b)(4).Visual examination at the macroscopic level reveals that the tap¿s distal end shaft portion had become fractured.Device was then sent for fracture analysis.The fracture analysis report reveals plastic deformation at the threads and torsional shear markings following a circular pattern.The plastic deformation at the threads indicates a torsional overload.This suggests that the tap underwent a quasi-static overload torsional shear failure.A review of the device history record was conducted.No issues were identified during the manufacturing and release of this product that could have contributed to the problem reported by the customer.A trend analysis was conducted.No emerging trends were found requiring further actions.A definitive root cause for the tap¿s threaded ended shaft portion becoming fractured cannot be positively determined.However, the fracture analysis report suggests that the tap underwent a quasi-static overload torsional shear failure.No issues were identified in the manufacturing and release of this device that could have contributed to the problem reported by the customer.Therefore, this complaint file will be closed with no further action required.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: MOD 5MM TAP
• Common Device Name: UNKNOWN
• Manufacturer (Section D): DEPUY SYNTHES SPINE; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7068359
• Report Number: 1526439-2017-50022
• Device Sequence Number: 16563334
• Product Code: LXH
• UDI-Device Identifier: 10705034328867
• UDI-Public: 10705034328867
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 698331539
• Device Lot Number: 1209NG
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2017
• Initial Date Received by Manufacturer: 11/07/2017
• Supplement Date Received by Manufacturer: 12/11/2017
• Initial Report FDA Received Date: 11/29/2017
• Supplement Report FDA Received Date: 12/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 36 YR