MAUDE Adverse Event Report: OSSIO LTD. OSSIOFIBER COMPRESSION SCREW 4.0X44 MM; SCREW, FIXATION, BONE

Model Number	OF1024044S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Malunion of Bone (4529)
Date of Event	12/03/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Surgeon reported a broken device in 1st ipj fusion, 3 weeks post-op, causing a dorsal wound.Removal surgery performed the next day.Immediate post-op imaging showed good alignment and stability.It was reported that the patient had pre-existing medical conditions and was weight-bearing on day 1 post-op, contrary to the surgeons' recommendations.The actual device could not be examined as it was not provided to the company.An investigation was performed including internal analysis of records, and surgeons' feedback.There is no indication of a design, manufacturing or process issue affecting implant safety or effectiveness.The investigation concluded that this event was the outcome of patient non-compliance with post-operative care recommendations resulting in implant breakage.The instructions for use include precautions that the patient is warned that the device might break or be damaged as a result of early weight bearing.It also emphasizes correct patient selection and contraindicates use in patients where post-op compliance cannot be guaranteed.Although the company does not believe that the device directly caused the injury, this event is being reported out of an abundance of caution.Company continues to monitor these events as part of post market activities.Additional report from the initial importer relating to this event: #3014323288-2021-00004.
Event or Problem Description
Broken ossiofiber compression screw 4.0x44 mm in first ipj fusion, 3 weeks post-op, causing a dorsal wound.Removal surgery performed.

• Brand Name: OSSIOFIBER COMPRESSION SCREW 4.0X44 MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): OSSIO LTD.; 8 hatochen st.; caesarea, 30798 61; IS 3079861
• Manufacturer (Section G): OSSIO LTD.; 8 hatochen st.; caesarea, 30798 61; IS 3079861
• Manufacturer Contact: taly lindner ; 8 hatochen st.; caesarea, 30798-61 ; IS 3079861
• MDR Report Key: 13105907
• Report Number: 3014554088-2021-00004
• Device Sequence Number: 4589573
• Product Code: HWC
• UDI-Device Identifier: 07290017630229
• UDI-Public: (01)07290017630229(17)221115(11)201116(10)OF00331
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K193360
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/29/2021

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: 11/15/2022
• Device Model Number: OF1024044S
• Device Catalogue Number: OF1024044S
• Device Lot Number: OF00331
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/03/2021
• Initial Report FDA Received Date: 12/29/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/16/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 48 YR
• Patient Sex: Male
• Patient Weight: 113 KG