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U.S. Department of Health and Human Services

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

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BIOMET UK LTD. TI LOW PROFILE SCREW 6.5X15MM; HIP PROTHESIS Back to Search Results
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.
 
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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 Key7159644
MDR Text Key97104613
Report Number3002806535-2018-00010
Device Sequence Number1
Product Code HWC
Combination Product (y/n)N
Reporter Country CodeKS
PMA/PMN Number
PN/A
Number of Events Reported1
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 Number103530
Device Lot Number2015030238
Other Device ID NumberSEE H10
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 12/08/2017
Initial Date FDA Received01/03/2018
Supplement Dates Manufacturer Received06/15/2018
Supplement Dates FDA Received06/15/2018
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 NumberN/A
Patient Sequence Number1
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