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

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.

• Brand Name: AO QC DRILL BIT 2.5/110/85 (GOLD)
• Type of Device: FLUTED 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 Key: 9871745
• MDR Text Key: 221302070
• Report Number: 3008951116-2020-00004
• Device Sequence Number: 1
• Product Code: HTW
• 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 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 Received: 03/24/2020
• 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: 1A2869
• 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 Received: 02/28/2020
• Was Device Evaluated By Manufacturer?: Device Not Returned To Manufacturer
• Date Device Manufactured: 09/19/2019
• 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