MAUDE Adverse Event Report: STRYKER GMBH LAT ASSEMBLY, RAD STEM HEAD IMPLANT, SIZE 4; ELBOW JOINT RADIAL (HEMI-ELBOW) POLYMER PROSTHESIS

Catalog Number 3100010

Device Problem Unsealed Device Packaging (1444)

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

Event Date 03/04/2013

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device will not be returned.If additional information becomes available, it will be provided on a supplemental report.(b)(4).

Event Description

On opening the lateral radial head, it was found that the head was out of the sterile package and floating in the box.The outside plastic wrap on the box was intact.The implant was flashed and used.

• Brand Name: LAT ASSEMBLY, RAD STEM HEAD IMPLANT, 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: 5316712
• MDR Text Key: 34747712
• Report Number: 0008031020-2015-00554
• Device Sequence Number: 1
• Product Code: KWI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K070236
• 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: 03/04/2013

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 Catalogue Number: 3100010
• Device Lot Number: 21912901
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/04/2013
• 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