MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG, ASSY, TITANIUM INTRALINE ANCHOR, 5.5MM W/NEEDLES; SCREW, FIXATION, BONE

Model Number 3910-400-055

Device Problems Device Contamination with Chemical or Other Material (2944); Packaging Problem (3007)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/14/2021

Event Type  malfunction  

Manufacturer Narrative

Additional information will be provided once the investigation has been completed.

Event Description

It was reported that there was foreign material in the sterile packaging.

Event Description

It was reported that there was foreign material in the sterile packaging.

Manufacturer Narrative

This complaint investigation was closed based on the device not received, therefore the reported failure mode was not confirmed.In the event that the device is received, the complaint will be reopened and the investigation will be updated with new results.Alleged failure: packaging compromised.Probable root cause: process uncontrolled environmental conditions.The reported failure mode will be monitored for future reoccurrence.H3 other text : 81.

• Brand Name: PKG, ASSY, TITANIUM INTRALINE ANCHOR, 5.5MM W/NEEDLES
• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 11805434
• MDR Text Key: 252755679
• Report Number: 0002936485-2021-00255
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 07613154890071
• UDI-Public: 07613154890071
• Combination Product (y/n): N
• PMA/PMN Number: K071157
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 06/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3910-400-055
• Device Catalogue Number: 3910-400-055
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/16/2021
• Initial Date FDA Received: 05/11/2021
• Supplement Dates Manufacturer Received: 04/16/2021
• Supplement Dates FDA Received: 06/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1