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	10/25/2018
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
The following was reported: t10-pelvis; ((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.Dr (b)(6) was using the ball tip feeler to find the entry point into the pedicle to place the screw, ( this is his standard operating procedure) and he bent the tip of the feeler.He asked that it be replaced.There was no delay in surgery.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Udi: (b)(4).Lot #: gm4625601.

• 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: 8059628
• Report Number: 1526439-2018-51054
• Device Sequence Number: 1225693
• 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
• Report Date (Section B): 10/26/2018

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: GM4625601
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/26/2018
• Supplement Date Received by Manufacturer: 11/18/2018
• Initial Report FDA Received Date: 11/12/2018
• Supplement Report FDA Received Date: 12/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 79 YR