MAUDE Adverse Event Report: BIOMET ORTHOPEDICS 25MM COMPR RVS CNTRL DPTH GAGE; PROSTHESIS, SHOULDER

Model Number N/A

Device Problem Device Reprocessing Problem (1091)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/15/2016

Event Type  malfunction  

Manufacturer Narrative

Current information is insufficient to permit a conclusion as to the cause of the event.There are warnings in the package insert that this type of an event can occur.Under care and handling of instruments, it states, "inspect the instrument case and instruments for damage upon receipt and after each use and cleaning." under cleaning and decontamination, number 1 states, "thoroughly clean instruments until visibly clean, repeating as necessary, prior to initial sterilization and as soon as possible after use." this report is number 1 of 3 mdrs filed for the same event (reference 1825034-2016-01712 / 01715 / 01716).Device requested, not yet received.

Event Description

Depth gauges cannot be cleaned properly due to a glue residue that cannot be washed off.There was no patient injury or delay in procedure.

Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.

Manufacturer Narrative

Upon reassessment of the reported event, it was determined to be not reportable.The initial report was forwarded in error and should be voided.

• Brand Name: 25MM COMPR RVS CNTRL DPTH GAGE
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: megan haas ; 56 e. bell drive; warsaw, IN 46582 ; 5743726700
• MDR Report Key: 5682594
• MDR Text Key: 46063824
• Report Number: 0001825034-2016-01712
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: PK120121
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 07/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 405829
• Device Lot Number: 2487123
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/11/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1