MAUDE Adverse Event Report: ALPHATEC SPINE, INC. SOLUS DISTAL WRENCH TIP (STAINLESS STEEL); HXC

Model Number	25909
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No evaluation possible at this time.The proximal section of the wrench tip has not been returned nor has the lot number been provided.Upon the receipt of additional information and/or the suspect device a follow up report will be submitted.Alphatec solus distal wrench tips are manufactured from (b)(4) (stainless steel) and certified to (b)(4).The tips are used in conjunction with the proximal and distal deployment wrenches in order to deploy the two blades of a solus spacer into the cephalad and caudal vertebral endplates of disc space.The blades of the solus spacer are deployed by the two counter-rotating wrenches (proximal and distal).The solus distal wrench tips are modular, replaceable tips intended for single use.The supplied instructions for use (ins-060) warning# 7 states; do not use with excessively dense vertebrae.In patients where only one of the two vertebrae is excessively dense the safety feature built into the deployment wrench tip will not be effective.
Event or Problem Description
The distal tip of the instrument broke off in the implant when the surgeon was turning the deployment wrench handles.The tip remains within the implant positioned between the l5-s1.Although the patient had very hard sclerotic bone, both blades of the implant were able to be completely deployed.

• Brand Name: SOLUS DISTAL WRENCH TIP (STAINLESS STEEL)
• Common Device Name: HXC
• Manufacturer (Section D): ALPHATEC SPINE, INC.; 5818 el camino real; carlsbad CA 92008
• MDR Report Key: 7735893
• Report Number: 2027467-2018-00052
• Device Sequence Number: 920143
• Product Code: HXC
• UDI-Device Identifier: 00844856062719
• UDI-Public: (01)00844856062719
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/28/2018

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 Model Number: 25909
• Device Catalogue Number: 25909
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/03/2018
• Initial Report FDA Received Date: 07/31/2018
• 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: Other