MAUDE Adverse Event Report: TITAN SPINE, LLC ENDOSKELETON TA SLAP HAMMER; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	2106-1002
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/22/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Note: this regulatory report was previously submitted on 21-feb-2018 as regulatory report # 3006340236-2017-00027 ¿ 1 with "follow-up".Per request, it is being resubmitted as an initial report.The product was returned for evaluation.It was determined that the failure of the threaded tip of the slap hammer was likely due to misuse by the user in bending and manipulating the threaded connection off axis.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the threaded tip of the slap hammer broke off into the handle of the threaded inserter.The incident occurred during an alif l3-s1 procedure while removing the rasp from l4-5.The surgeon did not use the rasps any further.As an alternative, the physician used smooth dilators.There were no reported adverse effects or injury to the patient.

• Brand Name: ENDOSKELETON TA SLAP HAMMER
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): TITAN SPINE, LLC; 6140 w. executive dr. suite a; mequon WI 53092
• Manufacturer (Section G): TITAN SPINE, LLC; 6140 w. executive dr. suite a; mequon WI 53092
• Manufacturer Contact: jane rodd ; 6140 w. executive dr. suite a; mequon, WI 53092 ; 2622427801
• MDR Report Key: 7287589
• Report Number: 3006340236-2017-00027
• Device Sequence Number: 2437520
• Product Code: LXH
• UDI-Device Identifier: 00191375000426
• UDI-Public: 00191375000426
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K111626
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/13/2020

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 Model Number: 2106-1002
• Device Catalogue Number: 2106-1002
• Device Lot Number: N140851
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/22/2017
• Supplement Date Received by Manufacturer: 11/22/2017
• Initial Report FDA Received Date: 02/21/2018
• Supplement Report FDA Received Date: 02/21/2018
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2014
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown