MAUDE Adverse Event Report: DEPUY SPINE INC XPDM QUICK-CON DI POLY SCWDRVR; SCREWDRIVER

Model Number	279722400
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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
It was reported that after reprocessing of instrument, it was prepared for surgery.While preparation of the instruments, a particle fell out of the instrument.The customer wants to investigate if it is the metal abrasion due to waring out.The customer doubts that the instrument could reprocess properly in prospective to the securer standards.Also the tip of instrument broke off.
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.Visual examination of the returned device had its tip broken off.The driver tip is missing entirely.Fracture analysis was subsequently performed on the tip of the driver.Optical imaging of the fractured surface of the driver reveals plastic deformation at the driver¿s hex lobes and torsional shear markings following circular patterns.The plastic deformation at the hex lobes indicates torsional overload of the fractured tip.This suggests the fractured driver tip underwent quasi-static overload torsional shear failure.No particles of any kind were found during evaluation.No other defects were noted.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 the root cause of the driver tip breaking cannot be determined from the sample and the information provided.The results of fracture analysis have determined that a probable root cause is quasi-static overload torsional shear failure due to unexpectedly high forces placed on the tip 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, 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).

• Brand Name: XPDM QUICK-CON DI POLY SCWDRVR
• Common Device Name: SCREWDRIVER
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8492515
• Report Number: 1526439-2019-51514
• Device Sequence Number: 2015193
• Product Code: HXX
• UDI-Device Identifier: 10705034199344
• UDI-Public: (01)10705034199344
• Combination Product (Y/N): N
• 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,Followup
• Report Date (Section B): 03/14/2019

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 Model Number: 279722400
• Device Catalogue Number: 279722400
• Device Lot Number: MI48251
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2019
• Initial Date Received by Manufacturer: 03/14/2019
• Supplement Date Received by Manufacturer: 05/17/2019; 06/07/2019
• Initial Report FDA Received Date: 04/08/2019
• Supplement Report FDA Received Date: 06/06/2019; 06/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1