MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH MD.UNIVERSAL CEMENT RESTRICTOR; IMPLANT

Catalog Number B000-0240

Device Problems Detachment Of Device Component (1104); Material Integrity Problem (2978)

Patient Problem No Patient Involvement (2645)

Event Date 02/14/2014

Event Type  malfunction  

Event Description

It was reported that the largest fin of the medium universal cement plug was came off from the body of the cement plug so easily during demo.

Manufacturer Narrative

When completed, the investigation results will be submitted in a supplemental report.

Manufacturer Narrative

Device history review: review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other events reported for the reported manufacturing lot.Visual inspection: visual inspection was performed as part of the material analysis report (mar).Images of the device are included in the mar.The reported event was confirmed.The larger proximal flange was separated from the body and had been pressed onto the distal tip of the device.A material analysis has been performed.The report concluded: ¿the proximal flange of the restrictor plug fractured due to the application of an overload force in the proximal direction.The distal flange was also damaged due to a similar loading condition.While the cause of the overload can not (sic) be determined based only on this analysis, excessive bending force on the flanges from insertion into an undersized cavity could result in a similar failure.No material or manufacturing defects were observed.¿ conclusions: the proximal flange of the restrictor plug fractured due to the application of an overload force in the proximal direction.The investigation determined the plug was inserted into an undersized hole.There is no indication at this time that the design, materials, or manufacturing of the subject device contributed to the event.If additional information becomes available, this investigation will be reopened.

Event Description

It was reported that the largest fin of the medium universal cement plug was came off from the body of the cement plug so easily during demo.

• Brand Name: MD.UNIVERSAL CEMENT RESTRICTOR
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: beverly lima ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 3724073
• MDR Text Key: 4323640
• Report Number: 0002249697-2014-01032
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K924323
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/11/2014

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
• Device Operator: Other
• Device Expiration Date: 07/31/2018
• Device Catalogue Number: B000-0240
• Device Lot Number: 6M8531
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/11/2014
• Initial Date FDA Received: 04/03/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/08/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other