MAUDE Adverse Event Report: SYNTHES GMBH UNK - REDUCTION/RETRACTION/DISTRACTION INSTRUMENTS: SPINE; RONGEUR

Catalog Number UNK - REDUCT/RETRACT/DISTRACT

Device Problem Mechanical Problem (1384)

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

Event Date 04/20/2022

Event Type  malfunction  

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.This report is for an unknown kerrison collet/unknown lot.Part and lot number are unknown; udi number is unknown.Device available for evaluation: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Initial reporter occupation: reporter is a synthes employee.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 colombia reports an event as follows: it was reported that during a procedure on (b)(6) 2022, that the tightener tip was worn.This was discovered when trying to tighten the locking screws.It was also reported that the internal mechanism of the kerrison clamp was stuck, which prevented its use.This report is for an unknown kerrison collet.This is report 1 of 1 for (b)(4).Additional reports are captured under (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.B5: subsequent follow-up with the customer, additional information was received regarding the event.Therefore, the event description has been updated accordingly.D4: the catalog was reported as unknown on the initial report; and has been updated accordingly.H10: correction narrative: e1: the reporter information has been updated accordingly to reflect the correct information.

Event Description

Device report from colombia reports an event as follows: it was reported that during a procedure on (b)(6) 2022, that the tightener tip was worn.This was discovered when trying to tighten the locking screws.It was also reported that the internal mechanism of the kerrison clamp was stuck, which prevented its use.According to the report, the surgery was performed successfully without delay.It was further reported that it was not detected that the pieces were failing and they were replaced by others.It was reported that the status of the patient was in very good condition with satisfactory result.No additional information was provided.This report is for an unknown kerrison collet.This is report 1 of 1 for (b)(4).Additional reports are captured under (b)(4).

• Brand Name: UNK - REDUCTION/RETRACTION/DISTRACTION INSTRUMENTS: SPINE
• Type of Device: RONGEUR
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 14465741
• MDR Text Key: 300350995
• Report Number: 8030965-2022-03382
• Device Sequence Number: 1
• Product Code: HTX
• Combination Product (y/n): N
• Reporter Country Code: CO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK - REDUCT/RETRACT/DISTRACT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: UNKNOWN LOCKING/SET SCREWS
• Patient Sex: Male