MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 SOL SYS CEM PLUG DRILLS 4.5MM; DRILLS (BITS, SLEEVES, GUIDES) : DRILLS

Catalog Number	210804000
Medical Device Problem Codes	Break (1069); Material Fragmentation (1261)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/26/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).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
Item broke during surgery - moreland instrument set.
Additional Manufacturer Narrative
Investigation summary the instrument associated with this report was not returned.Depuy 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.If information is obtained that was not available for the initial medwatch , a follow-up medwatch, a follow-up medwatch will be filed as appropriate. .
Additional Manufacturer Narrative
Product complaint #: (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.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
The breakage happened during the removal of a cemented hip replacement in a first stage revision surgery.The 4.5 drill bit was being used to help clear the femoral canal when approx 5cm of the drill broke off in the patients femur.The decision was made at the time to leave the broken piece in situ rather than risk further bone loss by attempting removal.The 2nd stage revision was then carried out on 2nd october with no adverse affects.The decision was again made to leave the broken piece in place due to the position and risk of removal.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Product complaint (b)(4).Investigation summary :the instrument associated with this report was not returned.Depuy 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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: SOL SYS CEM PLUG DRILLS 4.5MM
• Common Device Name: DRILLS (BITS, SLEEVES, GUIDES) : DRILLS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7786259
• Report Number: 1818910-2018-66766
• Device Sequence Number: 13498097
• Product Code: HTW
• UDI-Device Identifier: 10603295086932
• UDI-Public: 10603295086932
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 07/26/2018

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: 210804000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/26/2018
• Supplement Date Received by Manufacturer: 10/30/2018; 03/18/2019; 04/25/2019
• Initial Report FDA Received Date: 08/15/2018
• Supplement Report FDA Received Date: 11/01/2018; 04/01/2019; 04/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1