MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 SP2 FEM LUG DRILL W/HUD END; DRILLS (BITS, SLEEVES, GUIDES) : DRILLS

Catalog Number	966202
Medical Device Problem Codes	Material Deformation (2976); Naturally Worn (2988)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Investigation summary: examination of the returned device found the cutting flutes to be damaged/worn.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.The returned device was a 966202 sp2 fem lug drill w/hud end.The sp2 fem lug drill w/hud end was reported for unknown reason.Three follow-ups were conducted with the complainant to obtain event additional information.Please verify what is the alleged deficiency of the reported instrument? no additional event information was received.Visual examination of the device revealed deformation and wear on the cutting flutes.There is no missing material.The damage to the cutting flutes is from repetitive contact with bone and the patella drill guide.The flats on the hudson end exhibit wear.The root cause is attributed to device wear from normal use and servicing.The wear on the cutting flutes is from heavy usage and repetitive contact with the patella drill guide based on the root cause of device damage from normal use and servicing as the root cause, the need for corrective action is not indicated.Complaint trends will be monitored by post market surveillance through (b)(4).Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Device was used for treatment, not diagnosis.
Event or Problem Description
The office sets instrument was reported for unknown reason.It did not affect surgery or patient.Examination of the returned device by the product analyst found the cutting flutes of the device to be damaged/worn.

• Brand Name: SP2 FEM LUG DRILL W/HUD END
• Common Device Name: DRILLS (BITS, SLEEVES, GUIDES) : DRILLS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• MDR Report Key: 8405071
• Report Number: 1818910-2019-86821
• Device Sequence Number: 10860168
• Product Code: HWE
• UDI-Device Identifier: 10603295247272
• UDI-Public: 10603295247272
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/13/2019

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: 966202
• Device Lot Number: D0908
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/13/2019
• Initial Report FDA Received Date: 03/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1