MAUDE Adverse Event Report: TITAN SPINE, LLC ENDOSKELETON® TL; SLAP HAMMER

Model Number	7200-1065
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/22/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The threaded connection between the tl slap hammer and tl slap hammer attachment sheared off the tl slap hammer and is still threaded into the tl slap hammer attachment.The tl slap hammer (b)(4) and tl slap hammer attachment (b)(4) were combined into a single piece design as part of a design iteration.This design had the tl slap hammer attachment welded to the tl slap hammer providing the instrument with greater strength than the threaded assembly.This eliminates the failure mode that occurred in this complaint condition.The updated instrument design iteration is replacing the existing instruments in endoskeleton® tl instrument sets.A review of the device history records of the subject devices was completed.No anomalies or non-conformances were generated during the manufacture of these devices that would have led to this complaint condition.
Event or Problem Description
The surgeon was using a trial to size the patient for an implant when he attempted to remove the instrument with the slap hammer.The threaded shaft of the slap hammer broke off while the slap hammer attachment was still attached.An xlif procedure was being performed.There were no adverse effects or harm to the patient as a result of the failure.The planned procedure was completed.

• Brand Name: ENDOSKELETON® TL
• Common Device Name: SLAP HAMMER
• Manufacturer (Section D): TITAN SPINE, LLC; 6140 w. executive dr. ste a; mequon WI 53092
• MDR Report Key: 6911977
• Report Number: 3006340236-2017-00012
• Device Sequence Number: 13758956
• Product Code: LXH
• UDI-Device Identifier: 00191375009375
• UDI-Public: (01)00191375009375(11)141201(10)N141201(240)72001065
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K140055
• 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): 10/03/2017

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: Physician
• Device Model Number: 7200-1065
• Device Catalogue Number: 7200-1065
• Device Lot Number: N141201
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/25/2017
• Initial Report FDA Received Date: 10/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1