MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD WOODSON DURA SEPARATOR 7; N/A

Model Number	285391
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/29/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The following information was received via medwatch uf/importer report #(b)(4) : "woodson elevator broke during surgery.Procedure: inspection of hardware t11 to l3 with l4-l5 laminectomy, l5 and iliac screws.Posterior fusion l3, l4, l5, s1, and sacroiliac joint with allograft bilaterally with fluoroscopic guidance and monitoring.Preexisting characteristics that may have contributed to the event: diabetes; hypertension;" in summary, a facility reported that the woodson dura separator 7 (285-391) broke during surgery.It was subsequently reported that no part fell into the surgical site.The broken part was removed from the surgical field.All parts were recovered.A replacement part was available for use.It was reported that the patient condition was stable.No injury, death or surgical delay was reported.
Additional Manufacturer Narrative
Reporting facility name: (b)(6).An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.
Additional Manufacturer Narrative
The woodson dura separator 7 (285-39) was not returned for evaluation; therefore, a definitive root cause could not be determined.Lot number information has been provided; manufacturing records were reviewed and no anomalies related to the reported issue was identified.It was determined that the issue breaking during use may be the result of rough handling or environmental damage.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.
Event or Problem Description
N/a.

• Brand Name: WOODSON DURA SEPARATOR 7
• Common Device Name: N/A
• Manufacturer (Section D): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; 11 cabot boulevard; mansfield MA
• Manufacturer (Section G): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; mansfield MA
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 16163238
• Report Number: 3014334038-2023-00001
• Device Sequence Number: 5794887
• Product Code: HAO
• UDI-Device Identifier: 10381780386438
• UDI-Public: 10381780386438
• Combination Product (Y/N): N
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2023

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: 285391
• Device Catalogue Number: 285-391
• Device Lot Number: 100088-1803
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/20/2022
• Supplement Date Received by Manufacturer: 02/22/2023
• Initial Report FDA Received Date: 01/13/2023
• Supplement Report FDA Received Date: 03/06/2023
• Date Device Manufactured: 03/31/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female
• Patient Weight: 68 KG