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

Model Number 388.750

Device Problem Material Integrity Problem (2978)

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

Event Date 03/01/2021

Event Type  malfunction  

Manufacturer Narrative

Product complaint #
=
> (b)(4).Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.Reporter is a j&j sales representative.The investigation could not be completed, no product was received; 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.

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2021, the patient underwent for a surgery.It was reported about a broken rod cutter.It was unknown how it occurred.In the report the customer also mentioned three other rod cutters.There was no surgery and patient impacted.This complaint involves four (4) devices.This report is for (1) table top rod cutter and bender.This report is 1 of 4 (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: d4: udi updated.D9: part returned.Investigation summary: background: customer reports a broken rod cutter.In the report three (3) other rode cutters, with different lot numbers were mentioned.Customer also uses the rod cutter to cut rods from other manufacturers: nuvasive / magec-rod.Signus / diplomat-system.Event date unknown.No surgery impact.No patient impact.This complaint involves four (4) devices.Investigation flow: damage.Visual inspection: the table top rod cutter and bender (p/n: 388.750, lot number: 6l66831) was received at us cq.Visual inspection of the complaint device showed there was a small chip broken off the base on the right side, and the knurled screw had peeling threads.Device failure/defect was identified.Dimensional inspection: a dimensional inspection was not performed due to post-manufacturing damage.Document/specification review: sm_108487 rev f (current) and rev e (manufactured) were reviewed.No design issues or discrepancies were identified.Complaint was confirmed.Investigation conclusion: this complaint is confirmed as a small chip had broken off the base on the right side, and the knurled screw had peeling threads.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.H3, h4, h6: device history lot; part: 388.750; lot: 6l66831; manufacturing site: umkirch; release to warehouse date: 29 jan 2020.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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: 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: 11620206
• MDR Text Key: 276440544
• Report Number: 8030965-2021-02617
• Device Sequence Number: 1
• Product Code: FZT
• UDI-Device Identifier: 10705034773766
• UDI-Public: 10705034773766
• 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: 03/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 388.750
• Device Catalogue Number: 388.750
• Device Lot Number: 6L66831
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2021
• Date Manufacturer Received: 05/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: TABLE TOP ROD CUTTER AND BENDER.; TABLE TOP ROD CUTTER AND BENDER.; TABLE TOP ROD CUTTER AND BENDER.