MAUDE Adverse Event Report: TELEFLEX MEDICAL BABCOCK FCPS 8.25" INSERT JAW; FORCEPS, GENERAL & PLASTIC SUR

Model Number	IPN007734
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/14/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
Event or Problem Description
Broken jaw.
Additional Manufacturer Narrative
Qn# (b)(4).Device history record was reviewed for notifications pertaining to incoming inspection, stock checks, and product returns.No concerns were noted with reference to 500412.(1) sample of 500412 was received for evaluation.The lot # is not consistent with pilling manufacturing and lacks the lifelok logo.This device is either >20 years old and beyond expected life or is fraudulently marked with the pilling trademark.This device should also bear the weck brand after the pilling brand regardless of age , but it does not appear on any surface of the device.The device part number is laser etched on the back side of the boxlock inconsistent with traditional pilling layout.The fracture plane was observed under magnification to determine that the break originated on the inside face of the jaw near the boxlock.The fracture progressed over time which is evident from the rust development within the fracture.1) sample of 500412 was received for evaluation.The lot # is not consistent with pilling manufacturing and lacks the lifelok logo.This device is either >20 years old and beyond expected life or is fraudulently marked with the pilling trademark.This device should also bear the weck brand after the pilling brand regardless of age , but it does not appear on any surface of the device.The device part number is laser etched on the back side of the boxlock inconsistent with traditional pilling layout and etching methods.The fracture plane was observed under magnification to determine that the break originated on the inside face of the jaw near the boxlock.The fracture progressed over time which is evident from the rust development within the fracture.A dimensional inspection was not required as part of this investigation.A functional inspection was not required as part of this investigation.No confirmed complaints were received in this range with the same issue.Isolated incident and beyond useful life.
Event or Problem Description
Broken jaw.

• Brand Name: BABCOCK FCPS 8.25" INSERT JAW
• Common Device Name: FORCEPS, GENERAL & PLASTIC SUR
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• MDR Report Key: 11603173
• Report Number: 3011137372-2021-00080
• Device Sequence Number: 11512946
• Product Code: GEN
• UDI-Device Identifier: 24026704530285
• UDI-Public: 24026704530285
• Combination Product (Y/N): N
• Initial Reporter Country: RP
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2021

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: IPN007734
• Device Catalogue Number: 500412
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2021
• Initial Date Received by Manufacturer: 03/18/2021
• Supplement Date Received by Manufacturer: 05/20/2021
• Initial Report FDA Received Date: 04/01/2021
• Supplement Report FDA Received Date: 05/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1