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

Catalog Number 09390110

Device Problems Break (1069); Material Fragmentation (1261)

Patient Problem No Code Available (3191)

Event Date 03/05/2015

Event Type  malfunction  

Event Description

Sales rep informed the following on the phone.Item ref 0939-0-110 was broken into many pieces when implanted.Surgeon took an other one of item ref 0939-0-110 and that one was broken into many pieces when implanted as well.There was about 5 minutes delay during the operation because the broken pieces had to be removed twice.Operation was completed with competitor's product.

Manufacturer Narrative

Additional information has been requested and if received, will be provided in the supplemental report upon completion of the investigation.Device not available.

Manufacturer Narrative

Reported event: an event regarding a fractured device involving exeter bone plugs was reported.The event was not confirmed.Method & results: -device evaluation and results: the reported fractured components were not returned for evaluation.-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 that there are no other similar events for the reported lot.Conclusions: the exact cause of the event could not be determined with the available information.Return of the reported devices for evaluation is required to complete the investigation for determining the root cause.No further investigation for this event is possible at this time as the device was not received by stryker orthopaedics.

Event Description

Sales rep informed the following on the phone.Item ref 0939-0-110 was broken into many pieces when implanted.Surgeon took an other one of item ref 0939-0-110 and that one was broken into many pieces when implanted as well.There was about 5 minutes delay during the operation because the broken pieces had to be removed twice.Operation was completed with competitor's product.

• Brand Name: EXETER 2.5 I M PLUG 10MM
• Type of Device: IMPLANT
• 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: william hanna ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4643427
• MDR Text Key: 5596124
• Report Number: 0002249697-2015-00977
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: K980843
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/05/2015

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: Health Professional
• Device Expiration Date: 12/31/2019
• Device Catalogue Number: 09390110
• Device Lot Number: L7365
• Other Device ID Number: STER. LOT QB1S6
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/24/2015
• Initial Date FDA Received: 03/31/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/22/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/09/2014
• 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