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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ORTHO SOLUTIONS UK LTD DRILL BIT 2.0MM X 123MM CALIBRATED FLUTED SURGICAL DRILL BIT, SINGLE-USE, STERILE

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ORTHO SOLUTIONS UK LTD DRILL BIT 2.0MM X 123MM CALIBRATED FLUTED SURGICAL DRILL BIT, SINGLE-USE, STERILE Back to Search Results
Model Number OS200020LC
Device Problem Fracture (1260)
Patient Problem No Information (3190)
Event Date 02/21/2020
Event Type  Malfunction  
Manufacturer Narrative

Review of the device history records confirmed that the product was supplied in conformance with ortho solutions specifications and no deviations or anomalies were identified in the manufacturing of the batch which may have contributed to the fracture. No tests on the complaint device could be conducted as the drill was not available to be returned. Trend analysis of the os200020lc drill has shown that the device is well-performing and no negative trend has been observed. Based on the clinical information provided regarding the surgical technique, a number of possibilities were identified which may have caused the failure of the drill bit. However, despite the findings from the investigation, a definitive root cause could not be determined. This is the 4th complaint for this product and based on the trend analysis, the failure rate is deemed to be low at (b)(4). Although it was not possible to determine the root cause of failure, there has been no indication of a new or emerging risk with this device, and no negative trend has been identified. Complaint condition has been identified as part of the risk assessment procedure, and no emerging or new risks have been identified.

 
Event Description

While the surgeon was drilling with the drill bit in right 1st mtj fusion procedure, it broke inside the patient and the fluted portion of the drill is embedded in the patient's bone. The surgeon decided that leaving it in would cause less harm. No additional patient injury or complications were reported.

 
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Brand NameDRILL BIT 2.0MM X 123MM CALIBRATED
Type of DeviceFLUTED SURGICAL DRILL BIT, SINGLE-USE, STERILE
Manufacturer (Section D)
ORTHO SOLUTIONS UK LTD
unit 5, west station business
spital road
maldon, essex CM9 6 FF
UK CM9 6FF
Manufacturer (Section G)
ORTHO SOLUTIONS UK LTD
unit 5, west station business
spital road
maldon, essex CM9 6 FF
UK CM9 6FF
Manufacturer Contact
samuel chong
unit 5, west station business
spital road
maldon, essex CM9 6-FF
UK   CM9 6FF
MDR Report Key9883035
MDR Text Key200761743
Report Number3008951116-2020-00005
Device Sequence Number1
Product Code HTW
Combination Product (Y/N)N
Reporter Country CodeUK
PMA/PMN NumberK111678
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial
Report Date 03/26/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/26/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberOS200020LC
Device Catalogue NumberOS200020LC
Device LOT Number1088789
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/09/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/07/2017
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 03/26/2020 Patient Sequence Number: 1
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