MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH EXETER 2.5 I M PLUG 10MM; INSTRUMENT

Catalog Number 09390110

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/25/2014

Event Type  malfunction  

Event Description

Sales rep.Reported that after surgery when packing up they realised that the plug broke off in the introducer.

Manufacturer Narrative

A supplemental report will be submitted upon completion of the investigation.

Manufacturer Narrative

An event regarding a fractured device involving an exeter bone plug was reported.The event was confirmed.Method & results: -device evaluation and results: the material analysis concluded that the plug fractured in off-axis overload.There was no evidence of manufacturing or material defects on the device feature evaluated.-medical records received and evaluation: not performed as no medical records were provided.-device history review: dhr review was satisfactory.-complaint history review: a complaint history review confirmed no other similar events for the reported lot.Conclusions: material analysis was performed on the returned bone plug.Analysis concluded that the plug fractured in off-axis overload.There was no evidence of manufacturing or material defects on the device feature evaluated.This would indicate that the plug may have been incorrectly presented and/or incorrectly impacted into the femoral canal.

Event Description

Sales rep.Reported that after surgery when packing up they realised that the plug broke off in the introducer.

• Brand Name: EXETER 2.5 I M PLUG 10MM
• Type of Device: INSTRUMENT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-LIMERICK; raheen business park; limerick NA
• Manufacturer Contact: beverly lima ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4322498
• MDR Text Key: 19722829
• Report Number: 0002249697-2014-04604
• Device Sequence Number: 1
• Product Code: LZN
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: K980843
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 09390110
• Device Lot Number: L6847
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/22/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/05/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other