MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SMALL HOWMEDICA BONE PLUG 1PK; IMPLANT

Catalog Number 6215-5-001

Device Problem Device Expiration Issue (1216)

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

Event Date 03/16/2015

Event Type  malfunction  

Event Description

It was reported that an expired bone plug was implanted.

Manufacturer Narrative

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

Manufacturer Narrative

An event regarding the implantation of a bone plug beyond its expiry date was reported.Conclusion: a review of the product labelling indicated that the correct expiry date was present on the packaging of the device at the time of implantation.The reported product which has an expiry date of 11-2014 (november 2014) indicated on the packaging was reportedly used in surgery on (b)(6) 2015.It is the responsibility of the user to verify the expiration date and ensure that the product is used within this time frame.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

Event Description

It was reported that an expired bone plug was implanted.

• Brand Name: SMALL HOWMEDICA BONE PLUG 1PK
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NA
• Manufacturer Contact: beverly lima ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4714850
• MDR Text Key: 5581246
• Report Number: 0002249697-2015-01317
• Device Sequence Number: 1
• Product Code: LZN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K951860
• 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: 03/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2014
• Device Catalogue Number: 6215-5-001
• Device Lot Number: CPPJK09BG
• Other Device ID Number: STER. LOT 0911UP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/15/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/27/2009
• 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