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 Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	03/21/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reportedly there was no patient involvement.Device is an instrument and is not implanted/explanted.Part 388.50, synthes lot 5214364, 5214365, supplier lot (b)(4): release to warehouse date: april 07, 2006.Supplier: (b)(4).No non-conformance reports (ncrs) were generated during production.Review of the device history record (dhr) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.A service and repair evaluation was completed: the customer reported the tube was loose and out of the track.The repair technician reported the tube was broken, and the spring and ratchet were worn.Worn out parts is the reason for repair.The cause of the issue is unknown.The following parts were replaced: tube, nut, ratchet, spring (set).The item was repaired and will be returned to the customer upon completion of the service and repair process.The evaluation was confirmed.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 a rod introduction pliers, for side-opening implants was not functioning properly.The set screw that secure the clip on the tube was not working correctly; it was loose and out of the track.This was identified during routine inspection; there was no patient or procedure involvement.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: 7468034
• Report Number: 2939274-2018-51940
• Device Sequence Number: 1195838
• 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: Health Professional
• Type of Report: Initial
• Report Date (Section B): 03/21/2018

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: A7PA13
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2018
• Initial Date Received by Manufacturer: 04/26/2018
• Initial Report FDA Received Date: 04/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1