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

Model Number	OS200125
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/28/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported complaint was risk assessed as medium risk.Historical analysis ofthe drill batch identified that this was the first reported issue for this batch.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.Visual analysis of the returned drill section did not show any indicative features to point towards a clear root cause for the fracture, and did not undermine the documented conformance to specification as reviewed.Due to the limited clinical information and no available imaging of the retained drill section, the root cause therefore could not be ascertained.Although it was not possible to determine the root cause of failure, the failure rate for the product remains to be low.
Event or Problem Description
Reportedly, during a quads repair surgical procedure, the drill bit fractured during use to drill soft bone.The drill tip was retained within the patient, and was unable to be retrieved.No additional complications were reported for the patient at the time of report.

• Brand Name: AO QC DRILL BIT 2.5/110/85 (GOLD)
• Common Device Name: FLUTED SURGICAL DRILL BIT, SINGLE-USE, PRODUCT CODE: HTW
• Manufacturer (Section D): ORTHO SOLUTIONS UK LTD; unit 5, west station business; spital road; maldon, essex CM9 6 FF; UK CM9 6FF
• MDR Report Key: 11397749
• Report Number: 3008951116-2021-00001
• Device Sequence Number: 11310334
• Product Code: HTW
• UDI-Device Identifier: 05055662931105
• UDI-Public: 010505566293110517251101101118808
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K102743
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: OS200125
• Device Catalogue Number: OS200125
• Device Lot Number: 1118808
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/01/2021
• Initial Report FDA Received Date: 03/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1