MAUDE Adverse Event Report: ORTHO SOLUTIONS UK LIMITED ULTOS FOOT PLATING SYSTEM; ULTOS¿ GENERAL FUSION STRAIGHT PLATE 2 HOLE

Lot Number	8495
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	05/31/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No further information could be received regarding the clinical conditions under which the plate may have broken from the surgeon/hospital at this time.A quality review of the device history record showed that the product was inspected upon completion of manufacturing in accordance to the design specification and passed.These products were further quality inspected at ortho solutions through the approved inspection control process and met all the design dimensions and material specification requirements.No design review necessary at this time.If any further information is made available this report will be re-opened for further investigation.Ortho solutions will continue to monitor any and all related complaints for data trending.
Event or Problem Description
The device is an implant trial intended for to assess adequate sizing and geometry of the required implant.The device was therefore mis-used and implanted into the patient.Post-operative fracture of this plate inside the patient was reported; subsequently a revision surgery has been undertaken to remove the broken plate from the patient.The level of patient compliance following the initial surgery is unknown.
Event or Problem Description
The device is an implant trial intended for to assess adequate sizing and geometry of the required implant.The device was therefore mis-used and implanted into the patient.Post-operative fracture of this plate inside the patient was reported; subsequently a revision surgery has been undertaken to remove the broken plate from the patient.The level of patient compliance following the initial surgery is unknown.
Additional Manufacturer Narrative
No further information could be received regarding the clinical conditions under which the plate may have broken from the surgeon/hospital at this time.A quality review of the device history record showed that the product was inspected upon completion of manufacturing in accordance to the design specification and passed.These products were further quality inspected at ortho solutions through the approved inspection control process and met all the design dimensions and material specification requirements.No design review necessary at this time.If any further information is made available this report will be re-opened for further investigation.Ortho solutions will continue to monitor any and all related complaints for data trending.External laboratory sem fractography and hardness testing yielded no gross material or manufacturing discontinuities.Based on the clinical information and the investigation findings, the root cause for the plate fracture was attributed to the use of the plate in an anatomical region which is not suitable for the general fusion straight plate, for which a specific plate is also offered in the system.

• Brand Name: ULTOS FOOT PLATING SYSTEM
• Common Device Name: ULTOS¿ GENERAL FUSION STRAIGHT PLATE 2 HOLE
• Manufacturer (Section D): ORTHO SOLUTIONS UK LIMITED; west station business park; spital road; maldon, essex, CM9 6 FF; UK CM9 6FF
• MDR Report Key: 8879332
• Report Number: 3008951116-2019-00004
• Device Sequence Number: 13829182
• Product Code: HRS
• UDI-Device Identifier: 05055662946475
• UDI-Public: 05055662946475
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K141784
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/30/2019

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 Lot Number: 8495
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/09/2019
• Supplement Report FDA Received Date: 08/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1