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

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	11/12/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history record for the production batch associated with the complaint was reviewed to confirm that the products were supplied in conformance with ortho solutions specifications.The device history records for the batch confirmed that the products were manufactured to specification, conforming to both dimensional requirements and visual quality control that includes checks for the presence of burrs, sharp edges and inclusions.The raw material certificates were also reviewed to check the material grade, chemical composition and material hardness.The raw material was confirmed to be within specification, and the mechanical properties were above the minimum values required by bs (b)(4) as specified on the material certificate.There were no deviations from specification and no concession was raised for this batch.The failure rate is (b)(4) which is deemed low.Visual inspection of the returned drill confirmed the reported complaint condition and showed that the device may have fractured upon initial use.Based on the investigation and the limited clinical information provided and the lack of the x-ray, the root cause for the drill bit fracture was unable to be ascertained.The complaint did not identify any new or emerging risks.Although the root cause could not be definitively ascertained, the investigation did not identify any deficiency or deviation with the drill.
Event or Problem Description
Drill broken during a total hip replacement procedure; the drill tip couldn't be found and subsequently, an x-ray was called into theatre to identify the drill tip.The fragment was found near the stem, so it would cause more damage trying to retrieve it.No other clinical information was available.

• Brand Name: AO QC DRILL BIT 2.5/110/85 (GOLD)
• Common Device Name: FLUTED SURGICAL DRILL BIT, SINGLE-USE
• 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: 11012540
• Report Number: 3008951116-2020-00010
• Device Sequence Number: 17267221
• Product Code: HTW
• UDI-Device Identifier: 05055662931105
• UDI-Public: 010505566293110517250701101116052
• 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): 12/15/2020

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: 07/01/2025
• Device Model Number: OS200125
• Device Catalogue Number: OS200125
• Device Lot Number: 1116052
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/16/2020
• Initial Report FDA Received Date: 12/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other