MAUDE Adverse Event Report: STRYKER GMBH RHEAD STANDARD EXTENDED STEM, 6MM COLLAR, SIZE 2; ELBOW JOINT RADIAL (HEMI-ELBOW) POLYMER PROSTHESIS

Catalog Number 4100101

Device Problem Tear, Rip or Hole in Device Packaging (2385)

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

Event Date 06/14/2013

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 small bone innovation, inc.Device will not be returned.If additional information becomes available it will be provided on a supplemental report.(b)(4).Device is not available to stryker.

Event Description

Implant breaking through packaging - sbi is currently conducting a recovery of packaged product associated with the packaging breach.This activity will repackage sbi product with a (2) year expiration date.Concurrently a new package design is under validation.

Event Description

Implant breaking through packaging - (b)(4) is currently conducting a recovery of packaged product associated with the packaging breach.This activity will repackage (b)(4) product with a (2) year expiration date.Concurrently a new package design is under validation.

• Brand Name: RHEAD STANDARD EXTENDED STEM, 6MM COLLAR, SIZE 2
• 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: 5316829
• MDR Text Key: 34765312
• Report Number: 0008031020-2015-00564
• Device Sequence Number: 1
• Product Code: KWI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102180
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/14/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2016
• Device Catalogue Number: 4100101
• Device Lot Number: 18528
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/16/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2011
• 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