MAUDE Adverse Event Report: ORTHO SOLUTIONS UK LIMITED DRILL BIT 2.5MM X 143MM; FLUTED SURGICAL DRILL BIT, SINGLE-USE

Model Number	OS200025L
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/14/2020
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 en 10088-3 as specified on the material certificate.There were no deviations from specification and no concession was raised for this batch.Simulated use testing of the complaint batch was conducted using a 30pcf sawbone block which incorporated a 40pcf cortical layer representative of dense bone quality, to simulate a range of scenarios consisting of a range of entry angles, and a drilling depth which is beyond that which is typically observed in clinical use.Each drill bit sample was subject to four insertions.The test revealed no deficiency in the functionality or performance of the drill bits, and demonstrated that the drill bits were mechanically robust.As the complaint drill was discarded, no analysis of the device could be conducted, and no further information was provided regarding the clinical use of the product.Although the root cause could not be definitively ascertained, the investigation did not identify any deficiency or deviation with the drill bits.
Event or Problem Description
Patient underwent a shoulder stabilization procedure, whereby the drill bit was used.During the routine 4-week post-op check-up it was identified in the x-ray that there was a 1-2cm fragment of the drill bit retained in the patient.The patient was informed, and shown the x-ray.No adverse effects, injuries, or further complications were reported.

• Brand Name: DRILL BIT 2.5MM X 143MM
• Common Device Name: FLUTED SURGICAL DRILL BIT, SINGLE-USE
• Manufacturer (Section D): ORTHO SOLUTIONS UK LIMITED; west station business park; spital road; maldon, essex, CM9 6 FF; UK CM9 6FF
• MDR Report Key: 10741418
• Report Number: 3008951116-2020-00009
• Device Sequence Number: 3246147
• Product Code: HTW
• UDI-Device Identifier: 05055662930801
• UDI-Public: 010505566293080117250801101118944
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K111678
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/27/2020

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: 08/01/2024
• Device Model Number: OS200025L
• Device Lot Number: 1118944
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/28/2020
• Initial Report FDA Received Date: 10/27/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other