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	08/20/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # = >b)(4).Udi: b)(4).Visual examination of the returned device found the distal tip has completely broken off.No fragments were returned.The anodization of the screw driver¿s color ring has completely worn off.There was no evidence of color on the ring.No other defects were identified.A manufacturing related potential cause was not suspected, therefore, no manufacturing record evaluation is required.Although no definitive root-cause can be determined it is likely the device encountered unintended forces such as over torque during use.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.
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
It was reported that this was a pelvic fixation procedure performed on (b)(6) 2019.The tip of the screwdriver (279722400) became stripped against the hard bone.Because fragments stuck in the screw core (179722880), the screw was also removed and replaced.The surgery was completed less than a 30-minute surgical delay.No further information is available.Concomitant device reported: di polyaxl screw 8 x 80mm (part#: 179722880, lot#: unknown, quantity: unknown).This complaint involves one (1) device.
Additional Manufacturer Narrative
Product complaint # (b)(4).Udi: (b)(4).Additional information: d10.

• 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: 9003661
• Report Number: 1526439-2019-52063
• Device Sequence Number: 2528888
• 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: foreign,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/20/2019

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: 0208MI
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2019
• Initial Date Received by Manufacturer: 08/20/2019
• Supplement Date Received by Manufacturer: 09/12/2019; 11/05/2019
• Initial Report FDA Received Date: 09/12/2019
• Supplement Report FDA Received Date: 10/02/2019; 11/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1