MAUDE Adverse Event Report: SYNTHES GMBH TABLE TOP ROD CUTTER AND BENDER; CUTTER, SURGICAL

Catalog Number 388.750

Device Problem Material Integrity Problem (2978)

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

Event Date 01/21/2021

Event Type  malfunction  

Manufacturer Narrative

Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 posterior spinal fusion for the treatment of infection, the rod holder broke when the rode was being cut.There was no surgical delay.The procedure was completed successfully.The patient was reported as stable.Concomitant devices reported: uss rod (part number unknown, lot tbadjr, quantity 1).This report involves one (1) table top rod cutter and bender.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Product complaint (b)(4).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.H10 additional narrative: d9: updated.H3, h6: the device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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.

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: d10 h3, h4, h6: part 388.750, lot 3405044: manufacturing site: umkirch.Release to warehouse date: march 30, 2010.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.H3, h6: a product investigation was completed: upon visual inspection of the complaint device, it can be seen that the screwed in handle for bending and cutting is broken off at the connection, this thus confirming the complaint description.In addition, the instrument is in a very used condition with impression marks and scratches all over, which is an indication of regular use through its eleven (11) years of lifespan.The investigation has shown that the cause of complained malfunction is a post-manufacturing caused use related damage at the device.Drawings and revisions are in accordance to device history record (dhr) of production lot.All relevant features are defined on the used drawing revisions of dhr of production lot.Furthermore, all parts went through final inspection before they had left the production.The complaint is confirmed as the handle is broken off, as reported.The review of the production history revealed that this item was manufactured according to the specifications.No manufacturing related issues that would have contributed to this complaint condition were found.There is no particularize information what's happened to this article by customer, unfortunately we are not able to determine the exact reason for this occurrence, but we assume that that high applied mechanical force could have led to this damage or/and that wear and tear from often use over the last 11 years have led to this damage.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post market surveillance.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.H11: corrected data: d9.

• Brand Name: TABLE TOP ROD CUTTER AND BENDER
• Type of Device: CUTTER, SURGICAL
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 11307438
• MDR Text Key: 233341830
• Report Number: 8030965-2021-00911
• Device Sequence Number: 1
• Product Code: FZT
• UDI-Device Identifier: 07611819053243
• UDI-Public: (01)07611819053243
• 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,Followup
• Report Date: 01/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 388.750
• Device Lot Number: 3405044
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2021
• Date Manufacturer Received: 03/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ROD PUSHER F/USS ÿ6; UNK - RODS: USS; VIPER2 STRAIGHT ROD-200MM