MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SOL SYS CEM PLUG DRILLS 8.0MM; DRILLS (BITS, SLEEVES, GUIDES) : DRILLS

Model Number	2108-08-000
Medical Device Problem Codes	Material Deformation (2976); Material Twisted/Bent (2981); Naturally Worn (2988)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Code Available (3191)
Date of Event	01/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).
Event or Problem Description
It was reported that the tip of reamer teeth were worn out and bent.There were no reported patient consequences.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: examination of the returned instrument partially confirmed the complaint.Depuy-synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary.H10 additional narrative: added: d10.Corrected: h3 and h6 (device).Removed material twisted/bent under device code.

• Brand Name: SOL SYS CEM PLUG DRILLS 8.0MM
• Common Device Name: DRILLS (BITS, SLEEVES, GUIDES) : DRILLS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10312285
• Report Number: 1818910-2020-16660
• Device Sequence Number: 19100724
• Product Code: HTW
• UDI-Device Identifier: 10603295086956
• UDI-Public: 10603295086956
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• 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,Followup
• Report Date (Section B): 07/13/2020

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: 2108-08-000
• Device Catalogue Number: 210808000
• Device Lot Number: A0304
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2020
• Initial Date Received by Manufacturer: 07/13/2020
• Supplement Date Received by Manufacturer: 07/22/2020
• Initial Report FDA Received Date: 07/23/2020
• Supplement Report FDA Received Date: 07/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1