MAUDE Adverse Event Report: BIOMET ORTHOPEDICS VERSA-DIAL COMPREHENSIVE ADAPTOR PROV; TEMPLATE

Model Number N/A

Device Problems Device Reprocessing Problem (1091); Fracture (1260)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

It was reported that a distributorship is returning multiple versa-dial trial adaptors for repair.The o-rings weakened after being sterilized several times, causing them to fracture during washing.The damaged items were not used during any surgical procedures.

Manufacturer Narrative

The product identification necessary to review manufacturing history was not provided.Current information is insufficient to permit a conclusion as to the cause of the event.The following sections could not be completed with the limited information provided.Date of event ¿ unknown.Lot number and expiration date - unknown.Manufacture date ¿ unknown.Evaluation in process but not yet complete.Upon completion of evaluation, a follow up report will be sent to the fda.This report is number 5 of 5 mdrs filed for the same event (reference 1825034-2015-02459 / 02463).

Manufacturer Narrative

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

Manufacturer Narrative

Examination of returned device found no evidence of product non-conformance.During the evaluation, it was noted that the root cause of the event was most likely the age of the device and wear caused by repeated sterilizations.Device most likely failed due to the device not being inspected for wear and disfigurement prior to use, which may have prevented the use of the instrument and its failure.

• Brand Name: VERSA-DIAL COMPREHENSIVE ADAPTOR PROV
• Type of Device: TEMPLATE
• 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: 4826499
• MDR Text Key: 5843265
• Report Number: 0001825034-2015-02463
• Device Sequence Number: 1
• Product Code: HWT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor,distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2015
• 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: 407201
• Device Lot Number: UNKNOWN
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/12/2015
• 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