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

Model Number	OS200125
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Information (3190)
Date of Event	12/12/2019
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.

• Brand Name: ORTHO SOLUTIONS DRILL BITS
• Common Device Name: AO 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 Key: 9602143
• Report Number: 3008951116-2020-00002
• Device Sequence Number: 14258222
• Product Code: HTW
• UDI-Device Identifier: 05055662931105
• UDI-Public: 05055662931105
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K102743
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/01/2024
• Device Model Number: OS200125
• Device Catalogue Number: OS200125
• Device Lot Number: 1A1347
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/17/2019
• Supplement Date Received by Manufacturer: 12/17/2019
• Initial Report FDA Received Date: 01/17/2020
• Supplement Report FDA Received Date: 02/13/2020
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown