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	08/30/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The reported mod t20 driver short was not returned to the complaints handling unit (chu) for evaluation.The product was received and evaluated by depuy australia.A device history record review did not find any issues that could have caused or contributed to the reported event.All complaint trends will be evaluated as a part of the depuy spine monthly complaint review meeting.Assessment is that this complaint is due to wear and tear.No issues could be identified in the manufacturing or release of this product.Therefore, this complaint 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.
Event or Problem Description
Removal of iliac screws from existing construct - l4-pelvis; (b)(6), (b)(6) hospital (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.No delay to surgery.No ae to patient.

• 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: 7920119
• Report Number: 1526439-2018-50924
• Device Sequence Number: 19194822
• 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
• 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/31/2018
• Initial Report FDA Received Date: 09/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 72 YR