MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 CEMENT RESTRICTOR INSERTER; CEMENT / CEMENT ACCESSORY

Catalog Number	546002000
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	08/02/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 the introducer for the cement restrictor had snapped where the threads are introduced into the cement restrictor.The cement restrictor was already placed in the patient's femur.The broken tip is threaded into the restrictor and no way to remove.
Additional Manufacturer Narrative
Depuy considers the investigation closed at this time.Should the 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.
Additional Manufacturer Narrative
The device associated with this report was not returned for evaluation.Depuy considers the investigation closed.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: CEMENT RESTRICTOR INSERTER
• Common Device Name: CEMENT / CEMENT ACCESSORY
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582
• MDR Report Key: 6831171
• Report Number: 1818910-2017-23737
• Device Sequence Number: 1406194
• Product Code: LXH
• UDI-Device Identifier: 10603295174462
• UDI-Public: 10603295174462
• Combination Product (Y/N): N
• Initial Reporter State: VT
• Initial Reporter Country: US
• PMA/510(K) Number: K800894
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/02/2017

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: 546002000
• Device Lot Number: 572976
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/02/2017
• Supplement Date Received by Manufacturer: 09/26/2017; 09/26/2017
• Initial Report FDA Received Date: 08/30/2017
• Supplement Report FDA Received Date: 10/19/2017; 10/19/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1