MAUDE Adverse Event Report: BIOMET MICROFIXATION HOLDER, NEEDLE; ORTHOPEDIC; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT, HALSEY NEEDLEHOLDER FINE TC

Model Number N/A

Device Problem Disassembly (1168)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

"ah" is etched on the instrument, indicating the instrument was manufactured between january through june in 1992.Current information is insufficient to permit a valid conclusion about the cause of this event.A follow up report will be sent upon completion of the device evaluation.

Event Description

It was reported that half of the insert fell out of the instrument.The incident did not occur during a procedure.

Manufacturer Narrative

One needle holder was returned without packaging.The product was visually evaluated and it was found that one of the tips had been bent and a portion of the tungsten carbide insert had broken off.There were scratches and normal signs of wear on the instrument; some discoloration was observed.The complaint was confirmed as the instrument is missing a portion of one of the tungsten carbide inserts.In the warnings and precautions section of the instructions for use for this product it is stated, ¿avoid undue stress or strain when handling or cleaning instruments.¿ the most likely cause of the complaint is determined to be excessive force by the user.The non-conformance database was reviewed and there was not a non-conformance found.There are no indications of manufacturing defects.

• Brand Name: HOLDER, NEEDLE; ORTHOPEDIC
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT, HALSEY NEEDLEHOLDER FINE TC
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer (Section G): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer Contact: michelle cole ; 1520 tradeport drive; jacksonville, FL 32218 ; 9047414400
• MDR Report Key: 6567366
• MDR Text Key: 75215681
• Report Number: 0001032347-2017-00389
• Device Sequence Number: 1
• Product Code: HXK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 05/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 51-6502
• Device Lot Number: UNKNOWN
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/20/2017
• 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: N
• Removal/Correction Number: N/A
• Patient Sequence Number: 1