MAUDE Adverse Event Report: STRYKER GMBH RHEAD RECON STEM IMPLANT NON-COATED, SIZE 4; ELBOW JOINT RADIAL (HEMI-ELBOW) POLYMER PROSTHESIS

Catalog Number RCNS460

Device Problem Unsealed Device Packaging (1444)

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

Event Date 07/26/2013

Event Type  malfunction  

Manufacturer Narrative

With guidance from the mdr policy branch of the fda, mdr reported by stryker (b)(4) as a result of a retrospective lookback of complaints resulting from the acquisition of assets from (b)(4).Device will not be returned.If additional information becomes available it will be provided on a supplemental report.The reported device was manufactured and distributed by (b)(4) and implanted prior to howmedica osteonics corp.¿s purchase of certain assets of (b)(4) on august 1, 2014.Stryker became legal manufacturer of this product on april 1, 2015 and has taken the responsibility for medical device reporting.Device is not available to stryker.

Event Description

Breach of package seal - (b)(6) is currently conducting a recovery of packaged product associated with the packaging breach.This activity will repackage (b)(6) product with a (2) year expiration date.Concurrently a new package design is under validation - seal test data obtained from supplier and indicates satisfactory results.

• Brand Name: RHEAD RECON STEM IMPLANT NON-COATED, SIZE 4
• Type of Device: ELBOW JOINT RADIAL (HEMI-ELBOW) POLYMER PROSTHESIS
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• Manufacturer (Section G): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• Manufacturer Contact: rose haas ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5319944
• MDR Text Key: 34791495
• Report Number: 0008031020-2015-00606
• Device Sequence Number: 1
• Product Code: KWI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K023604
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/30/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: RCNS460
• Device Lot Number: 22298401
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/30/2013
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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