MAUDE Adverse Event Report: DEPUY SPINE INC 1.2MM DRILL BIT, 10MM - AO; BIT, DRILL

Model Number	288320110
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Investigation summary background: it was reported that on (b)(4) 2019, the expedium spine system ultra strength rod 5.5 and 1.2mm drill bit was found to be broken during reverse logistics audit of returned device at millstone.There was no patient involvement and no additional information is available.Investigation flow: damage.Visual inspection: the 1.2mm drill bit, 10mm - ao (p/n 288320110, lot ng29709) was received by us cq and it was observed that the threaded portion on the distal tip of the drill bit was bent.The complaint condition is confirmed.Device failure/ defect identified? yes.Dimensional inspection: the outer 1.8 + 0 /- 0.05mm of the drill bit got measured.Drawing: mountaineer laminoplasty 1.8mm drill bits, (b)(4) rev f.Outer diameter: d = 1.8 + 0 /- 0.05mm.Caliper: ca 215p.Measured diameter = 1.76 mm.Conclusion: the measuring result does show conformity.The design, materials and finishing processes were found to be appropriate for the intended use of this device.Document/ specification review: the following drawing(s) was reviewed: mountaineer laminoplasty 1.8mm drill bits, (b)(4) rev f, g.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Complaint confirmed? yes.Investigation conclusion: a definitive assignable root cause for the post manufacturing damage could not be determined based on the provided information.No product design issues or manufacturing discrepancies that would contribute to the reported complaint condition were identified during this investigation.No new, unique or different patient harms were identified because of this evaluation.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Device history lot: a review of the receiving inspection (ri) for 10-12 drill guide was conducted identifying that lot number ng29709 was released in a single batch 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.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 (b)(6) 2019, the expedium spine system ultra strength rod 5.5 and 1.2mm drill bit was found to be broken during reverse logistics audit of returned device at millstone.There was no patient involvement and no additional information is available.This complaint involves two (2) devices.
Additional Manufacturer Narrative
Product complaint # : (b)(4).

• Brand Name: 1.2MM DRILL BIT, 10MM - AO
• Common Device Name: BIT, DRILL
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 9214600
• Report Number: 1526439-2019-52259
• Device Sequence Number: 16247947
• Product Code: HTW
• UDI-Device Identifier: 10705034221915
• UDI-Public: (01)10705034221915
• 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: other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2019

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: 288320110
• Device Catalogue Number: 288320110
• Device Lot Number: NG29709
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2019
• Initial Date Received by Manufacturer: 09/23/2019
• Supplement Date Received by Manufacturer: 12/16/2019
• Initial Report FDA Received Date: 10/21/2019
• Supplement Report FDA Received Date: 12/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1