MAUDE Adverse Event Report: DEPUY SPINE INC MOD X25 INNIE TIGHTENER LONG; DRIVER, PROSTHESIS

Catalog Number	698337540
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Not Applicable (3189)
Date of Event	05/22/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A complaint investigation will be performed.The complaint product is not available for the investigation.A supplemental report is not anticipated unless the results of the complaint investigation identify a corrective action or additional relevant information.Should the product become available, a physical evaluation will be conducted and a supplemental report filed with the results.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
Selective thoracic fusion.Dr (b)(6) was performing an ais spinal fusion and went to use the x25 final tightener, extra long shaft,to torque the set screw.He said that the instrument was burred and did not want to use it, it needed to be replaced.This sri instrument has been specifically made to enable dr (b)(6) to perform spinal correction movements, achieve segmental fixation and final tightening, at the same time.There is only one of these instruments on the set.He had to use the regular final tightener(regular x25 shaft).There was a minimal delay to the surgery.No ae to patient.

• Brand Name: MOD X25 INNIE TIGHTENER LONG
• Common Device Name: DRIVER, PROSTHESIS
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7614519
• Report Number: 1526439-2018-50569
• Device Sequence Number: 19214781
• Product Code: HWR
• UDI-Device Identifier: 10705034377377
• UDI-Public: (01)10705034377377
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/22/2018

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: 698337540
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/22/2018
• Initial Report FDA Received Date: 06/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 YR