MAUDE Adverse Event Report: DEPUY ORTHOPAEDIC INC, 1818910 BIOSTOP G CEM RESTR 14MM; DEPUY CMW RESORBABLE BIOMATERIALS : CEMENT CENTRALIZER/PLUG

Catalog Number	546314000
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/23/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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
Occurrence: cement restrictor breaking at the time of use.Details: on (b)(6) 2018, in the total hip arthroplasty surgery, using the 14 mm bio cement restrictor, it was broken.According to reports this is not the first time this happens.For this new event, he called attention to record what happened.It was identified that the instruments used today in the c-stem amt stem box, "is not compatible with the plug (cement restrictor)".We request clarification as to the instruments and techniques of use so that the problem does not happen again.Product available for analysis.Product information: (b)(4) and lot: 16f1306005.
Additional Manufacturer Narrative
Additional Manufacturer Narrative
Product complaint # pc-(b)(4).Investigation summaryexamination of the returned device confirmed the reported breakage.Based on the provided information and the preformed investigation, a definitive root cause cannot be determined.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: BIOSTOP G CEM RESTR 14MM
• Common Device Name: DEPUY CMW RESORBABLE BIOMATERIALS : CEMENT CENTRALIZER/PLUG
• Manufacturer (Section D): DEPUY ORTHOPAEDIC INC, 1818910; . 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7269835
• Report Number: 1818910-2018-53416
• Device Sequence Number: 14021761
• Product Code: JDK
• UDI-Device Identifier: 10603295174578
• UDI-Public: 10603295174578
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K943727
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/31/2018

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: 546314000
• Device Lot Number: 16F1306005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2018
• Initial Date Received by Manufacturer: 01/31/2018
• Supplement Date Received by Manufacturer: 03/19/2018; 05/16/2018
• Initial Report FDA Received Date: 02/14/2018
• Supplement Report FDA Received Date: 04/04/2018; 05/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1