MAUDE Adverse Event Report: STRYKER GMBH LAT ASSEMBLY, RAD STEM IMPLANT,COLLAR 6MM,SIZE2; ELBOW JOINT RADIAL (HEMI-ELBOW) POLYMER PROSTHESIS

Catalog Number 3100005

Device Problem Packaging Problem (3007)

Patient Problem No Patient Involvement (2645)

Event Date 08/07/2017

Event Type  malfunction  

Manufacturer Narrative

Once the investigation has been completed, any additional information will be reported in a supplemental report.

Event Description

It was reported that in performing a procedure for a radial head replacement procedure, rep opened a package labelled as cat # 310-005.Inside the box was cat # 311-0507, lot 071720.Rep reported that getting the correct device caused a 20-30 minute surgical delay.Original box was discarded but rep can obtain the box stickers.Incorrect part is available for return.Surgical delay of 20-30 minutes.

Manufacturer Narrative

The reported event that the label on the package of a lat assembly, rad stem implant,collar 6mm,size2 reported "310-0005" and that the device inside was "311-0507" could be confirmed.The complaint investigation revealed that this is intentional."311-0507" is the device identifier, "310-0005" is the system one (including labels, packaging, etc.).A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If any further information is provided, the investigation report will be updated.

Event Description

It was reported that in performing a procedure for a radial head replacement procedure, rep opened a package labelled as cat # 310-005.Inside the box was cat # 311-0507, lot 071720.Rep reported that getting the correct device caused a 20-30 minute surgical delay.Original box was discarded but rep can obtain the box stickers.Incorrect part is available for return.Surgical delay of 20-30 minutes.

• Brand Name: LAT ASSEMBLY, RAD STEM IMPLANT,COLLAR 6MM,SIZE2
• 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: 6828653
• MDR Text Key: 84097734
• Report Number: 0008031020-2017-00502
• Device Sequence Number: 1
• Product Code: KWI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062898
• 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: 10/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 3100005
• Device Lot Number: 10163-L19
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/07/2017
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Age: 76 YR