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

Model Number IPN007734

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/14/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.

Event Description

Broken jaw.

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 Description

Broken jaw.

• Brand Name: BABCOCK FCPS 8.25" INSERT JAW
• Type of Device: FORCEPS, GENERAL & PLASTIC SUR
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• MDR Report Key: 11603173
• MDR Text Key: 247285139
• Report Number: 3011137372-2021-00080
• Device Sequence Number: 1
• Product Code: GEN
• UDI-Device Identifier: 24026704530285
• UDI-Public: 24026704530285
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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 Manufacturer Received: 03/18/2021
• Initial Date FDA Received: 04/01/2021
• Supplement Dates Manufacturer Received: 05/20/2021
• Supplement Dates FDA Received: 05/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1