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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ORTHO SOLUTIONS UK LTD AO QC DRILL BIT 2.5/110/85 (GOLD) FLUTED SURGICAL DRILL BIT, SINGLE-USE, STERILE

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ORTHO SOLUTIONS UK LTD AO QC DRILL BIT 2.5/110/85 (GOLD) FLUTED SURGICAL DRILL BIT, SINGLE-USE, STERILE Back to Search Results
Model Number OS200125
Device Problem Fracture (1260)
Patient Problem No Information (3190)
Event Date 02/27/2020
Event Type  Malfunction  
Manufacturer Narrative

Review of the device history records confirmed that the product was supplied in conformance with ortho solutions specifications. No anomalies or deviations were noted in the manufacture of this batch of drills which may have contributed to the failure of the drill bit during operation. Thus, the manufacture of the batch is therefore not likely to have been a cause for the drill fracture reported. The investigation was limited as there was a lack of clinical information, and the complaint device was discarded, thus not allowing for visual inspection or testing for material anomalies and insight into the mode of fracture. Although it was not possible to determine the root cause of failure, the failure rate for the product remains to be low and there were no issues found with the manufacture of the batch of drills. The os200125 drill and other ortho solutions drills sharing a similar design were found to be well-performing when compared to reported rates in literature. Based on the product failure rate and the results from the investigations conducted, there are currently no corrective actions to be taken. This complaint will however be monitored through ortho solution's post market surveillance procedures for re-occurrence and any evidence of negative trend.

 
Event Description

The drill fractured during surgery. A second drill of the same product code was used to complete the surgery. The surgery was completed successfully with minor delay caused. Most of the drill tip (the fluted section) remains inside the patient. The surgeon decided not to attempt to remove the broken drill section. No additional patient injury or complications were reported.

 
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Brand NameAO QC DRILL BIT 2.5/110/85 (GOLD)
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 Key9871745
MDR Text Key221302070
Report Number3008951116-2020-00004
Device Sequence Number1
Product Code HTW
Combination Product (Y/N)N
Reporter Country CodeUK
PMA/PMN NumberK102743
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,USER FACI
Reporter Occupation
Type of Report Initial
Report Date 03/24/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/24/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberOS200125
Device Catalogue NumberOS200125
Device LOT Number1A2869
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 Received02/28/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/19/2019
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 03/24/2020 Patient Sequence Number: 1
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