MAUDE Adverse Event Report: BIOMET SPINE - BROOMFIELD SET SCREW 5.5MM ROD TI

Model Number N/A

Device Problem Bent (1059)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/04/2016

Event Type  Injury  

Manufacturer Narrative

Product returned and lot numbers confirmed.The device evaluation is anticipated, a follow up report will be sent upon completion of the product evaluation.Report four of four for the same event, previously reported: 3004485144-2016-00095 and 00096.See also 3004485144-2016-00120.

Event Description

The sales associate reported screws that were damaged during surgery.The doctor was performing a lateral fusion procedure with telluride system.The set screw was bent as there was difficulty coming down on the rod, and the pedicle screw end tip was bent.

Manufacturer Narrative

The returned device was visually evaluated revealing that the set screw had retained some thread damage.It is likely that the screw was misaligned with the tulip head.The complaint is confirmed.The dhr shows that there were no nonconformances or manufacturing issues noted that may have contributed to the event.The reporting rep noted that the patient in the procedure had hard bone meaning this likely contributed to the damages that occurred with the set screw.

• Brand Name: SET SCREW 5.5MM ROD TI
• Type of Device: SCREW
• Manufacturer (Section D): BIOMET SPINE - BROOMFIELD; 310 interlocken parkway; suite 120; broomfield CO 80021
• Manufacturer (Section G): BIOMET SPINE - BROOMFIELD; 310 interlocken parkway; suite 120; broomfield CO 80021
• Manufacturer Contact: michelle cole ; 310 interlocken parkway; suite 120; broomfield, CO 80021 ; 3034437500
• MDR Report Key: 5741195
• MDR Text Key: 47909432
• Report Number: 3004485144-2016-00121
• Device Sequence Number: 1
• Product Code: KWP
• Combination Product (y/n): N
• PMA/PMN Number: PK100888
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/27/2016

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?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 7703-1600
• Device Lot Number: TC60020
• Other Device ID Number: 00888480530022
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/27/2016
• Initial Date FDA Received: 06/22/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/02/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• 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): Hospitalization; Required Intervention
• Patient Age: 52 YR