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 Codes	Break (1069); Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/19/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information not available for reporting.Device is an instrument and is not implanted/explanted.Dhr review was completed.Part number: 388.50.Synthes lot number: 6946399.Supplier lot number: n/a.Release to warehouse date: 24-jul-2012.Expiration date: n/a.Manufactured by (b)(4).Ncr was generated during production for 3 of 13 parts missing certs.Paperwork was reworked and all passed inspection.This non-conformance is not relevant to the complaint condition since it is not related to complaint condition of the device not holding while the instrument was depressed, a crack in the spring of the device, and rod bender with bend radius adjustment device was not working properly and might be missing a spring.Review of the device history record showed that there were no issues during the manufacture of this product, and any subcomponents, which would contribute to this complaint condition.Service & repair conducted an investigation of the returned device.Service & repair evaluation: the customer reported the pliers were not holding, and the spring was cracked.The repair technician reported the spring was broken, and the pliers were too tight.Leaf/spring broken is the reason for repair.The cause of the issue is unknown.The following parts were replaced: ratchet, spring (set).The item was repaired per the inspection sheet, passed synthes final inspection on 10-may-2018 and will be returned to the customer upon completion of the service and repair process.Attached service record router completed through operation 30.Finalized service record will be archived in docusphere document management system.The evaluation was confirmed.The device was deemed serviceable and 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.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 during an unknown spinal surgery on (b)(6) 2018, it was noted the rod introduction pliers for side-opening implants was not holding while the instrument was depressed.There was also a crack noted in the spring of the device.During the same procedure it was noted that the rod bender with bend radius adjustment was missing the spring, which prevented the device from tightening.Both devices were set aside and other similar devices were readily available and were used to complete the surgery successfully with no delay and no patient harm.The service and repair evaluation revealed the spring on the rod introduction pliers was broken and the pliers were too tight.This report is for one (1) rod introduction pliers for side-opening implants.This is report 1 of 1 for (b)(4).

• 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: 7516703
• Report Number: 2939274-2018-52194
• Device Sequence Number: 2012266
• Product Code: HTC
• UDI-Device Identifier: 10705034773292
• UDI-Public: (01)10705034773292
• Combination Product (Y/N): N
• Initial Reporter State: HI
• 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: Health Professional
• Type of Report: Initial
• Report Date (Section B): 03/20/2018

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: 6946399
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2018
• Initial Date Received by Manufacturer: 05/10/2018
• Initial Report FDA Received Date: 05/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1