MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC EXTRACTION SCREWDRIVER; SCREW, FIXATION,BONE

Catalog Number	352.311
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/19/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is an instrument and is not implanted/explanted.Device history records review was conducted.The report indicates that the part # 352.311 synthes lot # 5051794 supplier lot # (b)(4) release to warehouse date: 05 aug 2005 supplier: (b)(4).Mrr # (b)(4) was generated on 02 aug 2005 for a non-conformance of etch on inner shaft that does not match outer sleeve.Mrb review of product etch and drawing finds the parts conforming as of 02 aug 2005.This non-conformance for etch is not relevant to the complaint condition of broken subject device has been received and service & repair evaluation.A service & repair evaluation/review on (b)(6) 2018: service evaluation complete, item will be returned to customer.A service history review could not be performed because the device is a lot/batch controlled item.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.The customer reported the shaft broke off in the head of the removed screw.The repair technician reported the inner shaft of the extraction tip was broken.Tip broken is the reason for repair.The cause of the issue is unknown.The following parts were replaced: inner shaft.The item was repaired per the inspection sheet, passed synthes final inspection on (b)(6) 2018 and will be returned to the customer upon completion of the service and repair process.Attached service record router completed through operation 30.The evaluation was confirmed.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 anterior cervical fusion procedure on (b)(6) 2018 the removal screwdriver shaft for vectra broke off in the head of the removed screw.There is no report of patient harm or surgical delay.No additional information at this time.There is 1 device in this complaint.This report is 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Corrected data: date of event: it was previously reported on (b)(4) that the event date is (b)(6) 2018.The correct event date is (b)(6) 2018.It was previously reported on that the date of report and date received by manufacture was 2/20/2018.The correct date is 2/19/2018.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: EXTRACTION SCREWDRIVER
• Common Device Name: SCREW, FIXATION,BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7351753
• Report Number: 2939274-2018-51114
• Device Sequence Number: 69944
• Product Code: HXX
• UDI-Device Identifier: 10705034770765
• UDI-Public: (01)10705034770765(10)555359G05
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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,Followup
• Report Date (Section B): 02/20/2018

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 Catalogue Number: 352.311
• Device Lot Number: 555359G05
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2018
• Initial Date Received by Manufacturer: 02/20/2018
• Supplement Date Received by Manufacturer: 04/17/2018
• Initial Report FDA Received Date: 03/19/2018
• Supplement Report FDA Received Date: 04/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1