MAUDE Adverse Event Report: BIOMET UK LTD. TI LOW PROFILE SCREW 6.5X15MM; HIP PROTHESIS

Catalog Number 103530

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Patient Involvement (2645)

Event Date 11/15/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that when the product was opened there was no screw inside.

Manufacturer Narrative

(b)(4).Reported event was unable to be confirmed due to limited information received from customer.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: TI LOW PROFILE SCREW 6.5X15MM
• Type of Device: HIP PROTHESIS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• Manufacturer (Section G): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 7159644
• MDR Text Key: 97104613
• Report Number: 3002806535-2018-00010
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 103530
• Device Lot Number: 2015030238
• Other Device ID Number: SEE H10
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/08/2017
• Initial Date FDA Received: 01/03/2018
• Supplement Dates Manufacturer Received: 06/15/2018
• Supplement Dates FDA Received: 06/15/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1