MAUDE Adverse Event Report: BIOMET ORTHOPEDICS COMPREHENSIVE 10MM HUMERAL FRACTURE TRIAL; TEMPLATE

Model Number N/A

Device Problems Bent (1059); Device Dislodged or Dislocated (2923)

Patient Problem Tissue Damage (2104)

Event Date 04/24/2015

Event Type  Injury  

Event Description

It was reported that patient underwent initial shoulder arthroplasty on (b)(6) 2015.During the procedure, the trial stem became lodged in the patient when the inserter would not release.After many forced attempts with a mallet the inserter finally released, leaving it bent and unusable.A small humeral osteotomy was performed in order to remove the trial stem.A primary stem inserter was used for the final implant to complete the procedure.

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.Lot number and expiration date - unknown; manufacture date ¿ unknown.Device availability - the device is reported to be available for evaluation; however, it has not been received by biomet orthopedics to date.In the event that the device is received and evaluated, a follow up report will be sent to the fda to provide results.

Manufacturer Narrative

Examination of returned device found no evidence of product non-conformance.Returned device, item 31-406901 lot 035510, evaluated and reported under this device as it was the cause of serious injury.Evaluation of device found evidence that failure mode was likely due to misuse, and/or not inspected for wear and disfigurement prior to use.

Manufacturer Narrative

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

• Brand Name: COMPREHENSIVE 10MM HUMERAL FRACTURE TRIAL
• 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: 4791282
• MDR Text Key: 20718756
• Report Number: 0001825034-2015-02165
• 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: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 07/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 31-406910
• Device Lot Number: UNKNOWN
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/02/2015
• Initial Date FDA Received: 05/22/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 06/17/2015; 07/06/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention