MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD ARM 1362275 UNIVERSAL FLEXIBLE; PFM11

Model Number	1362275
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 3 of 3 reports linked to mfg report numbers: 3014334038-2022-00049, 3014334038-2022-00048.A facility reported that the universal flexible arm (1362275) 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.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields:  d4, d9, g3, g6, h2, h3, h4, h10.The universal flexible arm (1362275) was returned for evaluation: failure analysis & root cause - the reported complaint is confirmed.The returned 1362275 universal flexible arm is in used condition with the tip broken off due to insufficient soldering and excess tightening force at the end of the arm.Supplier corrective action has been initiated for this issue, and a recall was initiated for this product issue.

• Brand Name: ARM 1362275 UNIVERSAL FLEXIBLE
• 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: 13737749
• Report Number: 3014334038-2022-00050
• Device Sequence Number: 14569358
• Product Code: FXG
• UDI-Device Identifier: 10381780074670
• UDI-Public: 10381780074670
• 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
• Remedial Action: Recall
• 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: 1362275
• Device Catalogue Number: 1362275
• 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: 03/11/2022
• Supplement Report FDA Received Date: 03/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2021
• 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