MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC ROD INTRODUCTION PLIERS FOR SIDE-OPENING IMPLANTS; PLIERS,SURGICAL

Model Number	388.50
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/26/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.
Event or Problem Description
It was reported that on (b)(6) 2019, during a t10-ilium posterior spinal fusion with synthes spine uss, the tube of the rod introduction pliers for side-opening implant broke when putting in the rods.The fragment from the tube was retrieved and discarded.They were removed easily without additional intervention.Another persuader was already available so there was no surgical delay.The procedure was successfully completed.There was no harm to the patient.Concomitant device reported: unknown rods (part # unknown, lot # unknown, quantity # unknown).This complaint involves one (1) device.This report is for one (1) rod introduction pliers for side-opening implants.This is report 1 of 1 for (b)(4).
Additional 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.Additional narrative: a product investigation was conducted.Service & repair evaluation: the customer reported the tube of the rod introduction pliers for side-opening implant broke when putting in the rods.The fragment from the tube was retrieved and discarded.The item passed testing per the inspection sheet and worked within normal parameters.The complained issue was not able to be reproduced.The cause of the complained issue is unknown.The item will be returned to the customer upon completion of the service and repair process.The evaluation was unconfirmed.The device was deemed serviceable and will be returned to the customer, no design or manufacturing issues were identified therefore it has been determined that no corrective and/or preventative action is proposed.A device history record (dhr) review was conducted: part # 388.50.Synthes lot # 5660588.Supplier lot # a7qa48.Release to warehouse date: (b)(6) 2007.Supplier: (b)(4).No ncr's were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.Corrected data: mfr site: physical manufacturer 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.
Additional 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.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.
Additional 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, h6: part # 388.50, synthes lot # 5660588, supplier lot # a7qa48, release to warehouse date: 17 dec 2007, supplier: (b)(4), no ncr's were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.Visual inspection: the rod introduction pliers for side-opening implants (p/n: 388.50, lot number: 5660588) was received at us customer quality (cq).Upon visual inspection, the tube of the device has a piece broken off.Service & repair evaluation: the customer reported the tube of the rod introduction pliers for side-opening implant broke when putting in the rods.The fragment from the tube was retrieved and discarded.The item passed testing per the inspection sheet and worked within normal parameters.The complained issue was not able to be reproduced.The cause of the complained issue is unknown.The item was returned to the customer upon completion of the service and repair process.Attached service record router completed through operation 10.Finalized service record will be archived in tungsten document management system.The customer indicated the device still looked damaged upon receipt after repair, so the device was sent to west chester for investigation.Device failure/defect identified? yes.Dimensional inspection: measured dimensions: tube od = conforming.Document/specification review: current and manufactured were reviewed.No design issues or discrepancies were identified.Complaint confirmed? yes.Investigation conclusion: this complaint is confirmed as a piece of the tube has broken off.No definitive root cause could be determined based on the provided information.No new, unique or different patient harms were identified as a result of this evaluation.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.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: ROD INTRODUCTION PLIERS FOR SIDE-OPENING IMPLANTS
• Common Device Name: PLIERS,SURGICAL
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9188753
• Report Number: 2939274-2019-61529
• Device Sequence Number: 19447905
• Product Code: HTC
• UDI-Device Identifier: 10705034773292
• UDI-Public: (01)10705034773292
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/26/2019

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
• Operator of Device: Health Professional
• Device Model Number: 388.50
• Device Catalogue Number: 388.50
• Device Lot Number: 5660588
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2020
• Initial Date Received by Manufacturer: 09/26/2019
• Supplement Date Received by Manufacturer: 11/20/2019; 02/24/2020; 03/27/2020
• Initial Report FDA Received Date: 10/14/2019
• Supplement Report FDA Received Date: 11/22/2019; 03/02/2020; 04/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - RODS