MAUDE Adverse Event Report: DEPUY SPINE INC 2.4 DRILL; BIT, DRILL

Model Number	288301024
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation flow: damage.Visual inspection: the 2.4 drill (part #: 288301024/ lot #: ng86081 ) was received at us cq.The drill was broken off just proximal to the bit starting.No other defects were identified.The overall complaint was confirmed due to the broken condition of the bit.Device failure/defect identified? yes; drill bit was broken.Document/specification review: drawing(s) reviewed: (current & manufactured revisions).Conclusion: the overall complaint was confirmed for the received 2.4 drill.Although no definitive root-cause can be determined it¿s possible the device experienced unintended forces.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.Based on the investigation findings, it has been determined that 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.Device history lot: a review of the receiving inspection (ri) for the 2.4 drill was conducted identifying that lot number ng86081 was released in a single batch.Batch1: units were released on aug 16, 2019 with no discrepancies.As a result, the ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.Device history review: the ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.Device was used for treatment, not diagnosis.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 on an unknown date, the drill was received with an unknown allegation.The patient and procedure involvement were unknown.This is report 1 of 1 for (b)(4).

• Brand Name: 2.4 DRILL
• Common Device Name: BIT, DRILL
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 9617295
• Report Number: 1526439-2020-00429
• Device Sequence Number: 11443233
• Product Code: HTW
• UDI-Device Identifier: 10705034221151
• UDI-Public: (01)10705034221151
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/17/2020

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: 288301024
• Device Catalogue Number: 288301024
• Device Lot Number: NG86081
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/17/2020
• Initial Report FDA Received Date: 01/22/2020
• Patient Sequence Number: 1