MAUDE Adverse Event Report: DEPUY CMW - 9610921 BIOSTOP G CEM RESTR 14MM; DEPUY CMW RESORBABLE BIOMATERIALS : CEMENT CENTRALIZER/PLUG

Catalog Number	546314000
Medical Device Problem Codes	Fracture (1260); Difficult to Remove (1528); Connection Problem (2900)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/21/2019
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
At the moment of the placement of biostop plug number 12 after having correctly prepared the medullary canal, the surgeon introduces the cap with the corresponding setter.It is caught in the canal, but in an attempt by the surgeon to remove the plug from the cap, it decapitated.When this situation occurred, another biostop number 14 plug was opened, since the previous one had broken, but when placing this new implant, the same issue happened.Surgery: rtc hybrid, pinnacle / c-stem.
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 complaint states: ¿at the moment of the placement of biostop plug number 12 after having correctly prepared the medullary canal, the surgeon introduces the cap with the corresponding setter.It is caught in the canal, but in an attempt by the surgeon to remove the plug from the cap, it decapitated.When this situation occurred, another biostop number 14 plug was opened, since the previous one had broken, but when placing this new implant, the same issue happened.¿ the hospital has supplied photographs to aid investigation of this complaint (see attachment ¿(b)(4) photos.Pdf¿).The top ¿fin¿ has separated from the rest of the unit.The photographs confirm the complaint description.The complaint description states that 2 different sizes of restrictor (customer describes as ¿plug¿) were used, and this indicates that the sizing trial step may not have been completed correctly.Biostop restrictors are made to take compression load, but from the information available, it appears that when the surgeon was attempting to retract the introducer rod and restrictor holder (customer describes as ¿cap¿), torsional stress was applied and caused the biostop restrictor to break.The ifu for both the restrictor and the instrumentation set advise that they are designed for use with hand pressure only, and that excessive torsional stress should be avoided (see attachment ¿(b)(4) ¿ en ifu extracts.Pdf¿).Based on the information available, the root cause for this complaint is user error.No information received with this individual complaint indicated that a broader investigation or corrective action was necessary the number of complaints received for this failure mode will continue to be monitored and product updates/ recommendations will be implemented at the post market surveillance review dependent upon occurrence ratings.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 required.Device history lot = > device history reviewed: product is manufactured externally, therefore no device history available to review.Device history batch = > null.Device history review = > null.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.

• Brand Name: BIOSTOP G CEM RESTR 14MM
• Common Device Name: DEPUY CMW RESORBABLE BIOMATERIALS : CEMENT CENTRALIZER/PLUG
• Manufacturer (Section D): DEPUY CMW - 9610921; cornford rd; blackpool FY4 4 QQ; UK FY4 4QQ
• MDR Report Key: 8785819
• Report Number: 1818910-2019-98188
• Device Sequence Number: 19332621
• Product Code: JDK
• UDI-Device Identifier: 10603295174578
• UDI-Public: 10603295174578
• Combination Product (Y/N): N
• Initial Reporter Country: AR
• PMA/510(K) Number: K943727
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/21/2019

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 Expiration Date: 05/31/2021
• Device Catalogue Number: 546314000
• Device Lot Number: 18F1801009
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/21/2019
• Supplement Date Received by Manufacturer: 10/30/2019
• Initial Report FDA Received Date: 07/12/2019
• Supplement Report FDA Received Date: 11/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1