MAUDE Adverse Event Report: DEPUY SYNTHES SPINE 6MM DUAL-LEAD TAP; TAP, BONE

Catalog Number	279702600
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The expedium 6mm dual-lead tap (b)(4) was not returned to the customer quality unit.However, a photo of the device was provided.It was confirmed per the photo that the dual-lead tap had become fractured.A review of the device history record (dhr) for the expedium 6mm dual-lead tap could not be performed as no lot number was provided.All complaint trends will be evaluated as a part of the depuy spine monthly complaint review meeting.Without the return of the dual-lead tap a definitive root cause cannot be positively determined.Device was not returned for evaluation and as such a root cause analysis cannot be positively determined.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.
Event or Problem Description
Surgeon was tapping a prepared screw hole at l4 on the patient's left.When the surgeon dropped his hand to improve trajectory the tap sheared off at the point of the shaft where the larger diameter transitions to a smaller diameter shaft.The tap remained in the patient bone until the surgeon removed the remaining portion of the tap with a pair of pliers.Patient consequence? no.Action taken for procedure: removal of instrument with pliers.

• Brand Name: 6MM DUAL-LEAD TAP
• Common Device Name: TAP, BONE
• Manufacturer (Section D): DEPUY SYNTHES SPINE; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7213503
• Report Number: 1526439-2018-50061
• Device Sequence Number: 13708815
• Product Code: HWX
• UDI-Device Identifier: 10705034198637
• UDI-Public: 10705034198637
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/09/2018

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: Health Professional
• Device Catalogue Number: 279702600
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/09/2018
• Initial Report FDA Received Date: 01/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 49 YR