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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ORTHO SOLUTIONS UK LIMITED ORTHO SOLUTIONS DRILL BITS AO QC DRILL BIT 2.5/110/85 (GOLD)

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ORTHO SOLUTIONS UK LIMITED ORTHO SOLUTIONS DRILL BITS AO QC DRILL BIT 2.5/110/85 (GOLD) Back to Search Results
Model Number OS200125
Device Problem Fracture (1260)
Patient Problem No Information (3190)
Event Date 12/12/2019
Event Type  Malfunction  
Manufacturer Narrative

Initial review of historical data for the device and trending of the product has shown no negative trend in the performance or safety of the device. No new or emerging risks have been identified following risk evaluation of the reported issue. Following completion of the investigation, a supplementary report will be made to summarise the results of the investigation.

 
Event Description

It was reported that during a left tibial tubercle transfer and patellar stabilisation procedure that as the surgeon was drilling the tibia with the drill bit, the drill bit snapped as it contacted the distal cortex of the tibia. X-rays were done and the end of the drill was left in the tibia after further assessment by the consultant, as it was irretrievable. The patient was noted to have hard bone.

 
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Brand NameORTHO SOLUTIONS DRILL BITS
Type of DeviceAO QC DRILL BIT 2.5/110/85 (GOLD)
Manufacturer (Section D)
ORTHO SOLUTIONS UK LIMITED
west station business park
spital road
maldon, essex, CM9 6 FF
UK CM9 6FF
Manufacturer (Section G)
ORTHO SOLUTIONS UK LIMITED
west station business park
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 Key9602143
MDR Text Key196054494
Report Number3008951116-2020-00002
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 OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 01/17/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/17/2020
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 Number1A1347
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 Received12/17/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured05/01/2019
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: 01/17/2020 Patient Sequence Number: 1
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