MAUDE Adverse Event Report: DEPUY SPINE INC POLY DRIVER, 10MM; DRIVER, PROSTHESIS

Catalog Number	286760010
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/09/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device is available for evaluation.Investigation will be conducted.Follow up will be filed with the investigation 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
Pedicle finder: the metal core of the handle has been moved backwards causing the awl to not extend far enough at the tip of the article.The screwdriver: tip broken off making it impossible to safely attach screw.Reporter name: (b)(6).Position: produktspesialist spine hospital name: (b)(6).Does the complainant require an official response letter? no.Where / when did the event occur? intra - op.Was surgery time extended as a direct result of incident? no.What action was taken/required to manage the problem during the procedure? with same like product.Was a patient involved: no.Concomitant device reported: unknown screw (part#: unknown, lot#: unknown, quantity 1).Pedicle finder core (part#: unknown, lot#: mi20051, quantity 1).This compliant involves two (2) devices.
Additional Manufacturer Narrative
Product complaint # (b)(4).Udi: (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.Upon visual inspection, it is observed that the distal tip of the device got broken.The rest of the device shows normal wear which would not contribute to the complaint condition.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.A visual inspection, dimensional inspection, and document/ specification review were performed as part of this investigation.The complaint is being confirmed as the distal tip of the device got broken.While a definitive root cause could not be determined, it is possible that the device might have encountered unintended forces.No product design or manufacturing issues were identified, and no new malfunctions were identified either.Based upon these results, no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.

• Brand Name: POLY DRIVER, 10MM
• Common Device Name: DRIVER, PROSTHESIS
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 9263288
• Report Number: 1526439-2019-52348
• Device Sequence Number: 3671454
• Product Code: HWR
• UDI-Device Identifier: 10705034214887
• UDI-Public: 10705034214887
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/10/2019

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: 286760010
• Device Lot Number: MI19982
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2019
• Initial Date Received by Manufacturer: 10/10/2019
• Supplement Date Received by Manufacturer: 12/04/2019
• Initial Report FDA Received Date: 10/31/2019
• Supplement Report FDA Received Date: 12/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1