MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE 3.0MM GLENOID ANCHOR W/ 1 #2 FORCE FIBER SUTURE (5BX); FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number 3910-100-015

Device Problem Device Expiration Issue (1216)

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

Event Date 06/15/2016

Event Type  malfunction  

Manufacturer Narrative

Additional information will be provided once the investigation has been completed.(b)(4).

Event Description

It was reported that an expired anchor was implanted into a patient.

Manufacturer Narrative

The product was not returned for investigation therefore the reported failure mode was not confirmed.Alleged failure: expired anchor: probable root cause: design: validated shelf life too short application; distribution inefficient, sat too long in inventory before being shipped to customer.The failure mode will be monitored for future reoccurrence.Mfg date: 03/05/2014.(b)(4).

Event Description

It was reported that an expired anchor was implanted into a patient.

• Brand Name: 3.0MM GLENOID ANCHOR W/ 1 #2 FORCE FIBER SUTURE (5BX)
• Type of Device: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• Manufacturer (Section G): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• Manufacturer Contact: kimberly lynch ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 5807577
• MDR Text Key: 50663855
• Report Number: 0002936485-2016-00688
• Device Sequence Number: 1
• Product Code: MBI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K041310
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 3910-100-015
• Device Lot Number: 14064AE2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/24/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/05/2014
• 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