MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD MOUNT 1352277 QUICK-LOCK SPECULUM; PFM11

Model Number	1352277
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.
Event or Problem Description
This is 1 of 3 linked to mfg report numbers: 3014334038-2022-00048, 3014334038-2022-00050.A facility reported that the quick-lock speculum mount (1352277) broke in the middle of a tympanoplasty procedure.All parts were recovered and were taken off the surgical field; no fragments fell into the surgical site.It was reported that an x-ray was performed to assure that no parts were left in the patient following the event.The event did not lead to patient injury, death, or delay in procedure.
Additional Manufacturer Narrative
The quick-lock speculum mount (1352277) was returned for evaluation: failure analysis - evaluation was unable to conclusively verify customer information as valid.The mount was undamaged and no defect was found.Tested within specifications.Root cause - the returned 1352277 mount is in used condition with no visible defect.The mount was attached to a broken 1352275 speculum arm.The arm is being investigated under a separate complaint.No further investigation required based on the acceptability of risk and no adverse trends identified.This will be monitored and trended going forward.

• Brand Name: MOUNT 1352277 QUICK-LOCK SPECULUM
• Common Device Name: PFM11
• 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: 13742950
• Report Number: 3014334038-2022-00049
• Device Sequence Number: 4761894
• Product Code: FXG
• UDI-Device Identifier: 10381780074526
• UDI-Public: 10381780074526
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/25/2022

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: 1352277
• Device Catalogue Number: 1352277
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/18/2022
• Supplement Date Received by Manufacturer: 03/17/2022
• Initial Report FDA Received Date: 03/12/2022
• Supplement Report FDA Received Date: 03/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Unknown