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

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.

• Brand Name: ORTHO SOLUTIONS DRILL BITS
• Type of Device: 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
• MDR Text Key: 196054494
• Report Number: 3008951116-2020-00002
• Device Sequence Number: 1
• Product Code: HTW
• UDI-Device Identifier: 05055662931105
• UDI-Public: 05055662931105
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K102743
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• 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 Received: 01/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• 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
• Date Manufacturer Received: 12/17/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other