MAUDE Adverse Event Report: DEPUY SPINE INC PIPELINE ACCESS SYSTEM ANGLED PITUITARY WITH TEETH 4MM; RONGEUR

Model Number 288205042

Device Problem Break (1069)

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

Event Date 05/28/2021

Event Type  malfunction  

Manufacturer Narrative

The investigation could not be completed; no conclusion could be drawn, as no product was received.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2021, the tip of the instrument broke as the surgeon attempted to remove a piece of bone.No fragments generated.The patient and procedure outcome are unknown.This report is for (1) pipeline access system angled pituitary with teeth 4mm.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: d7.H3, h6: part: 288205042.Lot: 0209kw.Supplier: (b)(4).Batch1: released on february 17, 2009 with no discrepancies.No nonconformance reports (ncrs_ were generated during production.Visual inspection: the 4mm angled pituitary w/teeth was returned and received at us customer quality (cq).Upon visual inspection, it was observed that one of the jaws was broken and the broken piece was returned.No other issues were observed with the device.Dimensional inspection: a dimensional inspection for the received device was not performed due to post-manufacturing damage.Additionally, the complaint relevant dimensions cannot be checked for dimensional accuracy, because of the design of the device.Document/specification review: the following current and manufactured revisions were reviewed: -angled pituitary with teeth no design issues or discrepancies were identified.Investigation conclusion: this complaint is confirmed as the device was broken.No definitive root cause could be determined based on the provided information.There was no indication that a design or manufacturing issue contributed to the complaint.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.D9.

• Brand Name: PIPELINE ACCESS SYSTEM ANGLED PITUITARY WITH TEETH 4MM
• Type of Device: RONGEUR
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 12069768
• MDR Text Key: 258428780
• Report Number: 1526439-2021-01301
• Device Sequence Number: 1
• Product Code: HTX
• UDI-Device Identifier: 10705034220420
• UDI-Public: (01)10705034220420
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 288205042
• Device Catalogue Number: 288205042
• Device Lot Number: 0209KW
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2021
• Date Manufacturer Received: 07/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1