MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH T.L.I.F. SG INSTRUMENTS PITUITARY RONGEUR, STRAIGHT 4MM

Model Number 202716004

Device Problem Break (1069)

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

Event Date 05/17/2021

Event Type  malfunction  

Manufacturer Narrative

Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be 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, during a procedure, the rongeur tip broke from use.No fragments were generated.Surgeon used another rongeur to complete the procedure.The procedure was successfully completed without any surgical delay.There were no patient consequences reported.This report is for one (1) t.L.I.F.Sg instruments pituitary rongeur, straight 4mm this is report 1 of 1 for complaint (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.H3, h4, h6: a review of the receiving inspection (ri) for pituitary rongeur, 4mm straight was conducted identifying that lot number kw1943408 was released in a single batch.Batch1: released on november 21, 2019 with no discrepancies.As a result, the ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.Visual inspection: the pituitary roguer,4mm straight was returned and received at us customer quality (cq).Upon visual inspection, the pin that secures the movable jaw was observed to be out of position.Additionally, there were scratches on the device but have no impact on the device functionality.No other issues were observed with the returned device.Functional test: during the functional test, an attempt to push the pin was made to secure the movable jaw of the rongeur.The pin was got placed in its position and the device was able to function as intended.However a complete functional test could not be performed as the device was returned by itself.Dimensional inspection: complaint relevant dimensional analysis could not be performed as the internal components could not be accessed without the destruction of device.Document/specification review: based on the date of manufacture, the current and manufactured revision of drawings were reviewed.Intervertebral rongeur, 9" straight.Investigation conclusion: the overall complaint condition is confirmed for the returned device.However, the reported condition of broken could not be confirmed.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.The potential cause could be due to unintended forces applied to the device.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.

• Brand Name: T.L.I.F. SG INSTRUMENTS PITUITARY RONGEUR, STRAIGHT 4MM
• Type of Device: RONGEUR
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle MA 02400 ; SZ 02400
• MDR Report Key: 11971182
• MDR Text Key: 256073086
• Report Number: 1526439-2021-01201
• Device Sequence Number: 1
• Product Code: HTX
• UDI-Device Identifier: 10705034184487
• UDI-Public: (01)10705034184487
• 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: 05/17/2021

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: 202716004
• Device Catalogue Number: 202716004
• Device Lot Number: KW1943408
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2021
• Initial Date Manufacturer Received: 05/17/2021
• Initial Date FDA Received: 06/09/2021
• Supplement Dates Manufacturer Received: 06/17/2021
• Supplement Dates FDA Received: 07/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1