MAUDE Adverse Event Report: TITAN SPINE, LLC ENDOSKELETON TT IMPLANT HOLDER; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	4200-1001
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/30/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Note: this regulatory report was previously submitted on 22-feb-2018 as regulatory report # 3006340236-2017-00021 ¿ 1 with "follow-up" marked.Per request, it is being resubmitted as an initial report.The product was returned for evaluation and it was found that threads were broken off of the insertion end of the instrument.It was noted that the failure was likely attributed to misuse of the inserter beyond its intended use.It was also noted the cause of the malfunction was related to wear.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the tt cage inserter broke while the surgeon was inserting the cage during a plif procedure.This was the first of two cages to be inserted.The inside piece that threads with the cage broke off.The second tt inserter from the set was used.The malfunction did not have an adverse effect on the patient.

• Brand Name: ENDOSKELETON TT IMPLANT HOLDER
• 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: 7290811
• Report Number: 3006340236-2017-00021
• Device Sequence Number: 16748056
• Product Code: LXH
• UDI-Device Identifier: 00191375002987
• UDI-Public: 00191375002987
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K083714
• 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: 4200-1001
• Device Catalogue Number: 4200-1001
• Device Lot Number: UU160220
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/30/2017
• Supplement Date Received by Manufacturer: 10/30/2017
• Initial Report FDA Received Date: 02/22/2018
• Supplement Report FDA Received Date: 02/22/2018
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2016
• 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