MAUDE Adverse Event Report: DEPUY SPINE INC MOD T20 DRIVER SHORT; DRIVER, PROSTHESIS

Catalog Number	698337505
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/31/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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; (b)(6), (b)(6) hospital (b)(6) (b)(6) 2018.Dr (b)(6) was inserting pedicle screws under power and the tip of the t20 screwdriver shaft (short)) was burred.He asked that it be replaced.There was no delay in surgery.Action taken: there are x 2 instruments on the set and the 2nd one was used.No ae to patient.
Additional Manufacturer Narrative
(b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.The device was not returned to the complaint handling unit (chu).Only images of the driver were provided.The returned images show that the hexlobes at the tip of the driver are stripped.The damage is worst at the distal end of the hexlobes and it extends approximately one third of the way down their length.The damage is irregular and each hexlobe is worn to a degree similar to the others without actually matching.A review of the device history record was conducted.No issues were identified during the manufacturing and release of this product that could have contributed to the problem reported by the customer.All complaint trends will be evaluated as a part of the depuy spine monthly complaint review meeting.The root cause of the driver tip stripping could not be determined from the returned images.A potential root cause may be not fully inserting the instrument flush with the associated set screw during tightening.As there has been no issue identified in the manufacturing or release of the device that could have contributed to the problem reported by the customer and no systemic trends were found, this complaint file will be closed with no further action required.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Udi: (b)(4).

• Brand Name: MOD T20 DRIVER SHORT
• Common Device Name: DRIVER, PROSTHESIS
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7920211
• Report Number: 1526439-2018-50926
• Device Sequence Number: 2014706
• Product Code: HWR
• UDI-Device Identifier: 10705034377261
• UDI-Public: (01)10705034377261
• 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: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/31/2018

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: 698337505
• Device Lot Number: GM4286001
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/31/2018
• Supplement Date Received by Manufacturer: 10/24/2018; 11/15/2018
• Initial Report FDA Received Date: 09/28/2018
• Supplement Report FDA Received Date: 11/02/2018; 11/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 15 YR