MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TEN SYSTEM GRAPHIC CASE; TRAY,SURGICAL INSTRUMENT

Catalog Number	690.109
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	02/23/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient information not available for reporting.Device is an instrument and is not implanted/explanted.Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.(b)(4).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 the reamer/irrigator/aspirator (ria) instrument set and the titanium elastic nail (ten) system set were not delivered to sterile processing and, therefore, not sterilized for use on (b)(6) 2018.Patient was in pre-operative staging when the issue was noted.Surgery was cancelled and patient was notified to return home.Surgery was rescheduled for the following day, (b)(6) 2018.This report is for one (1) titanium elastic nail system set.This is report 2 of 2 for (b)(4).
Additional Manufacturer Narrative
Corrected data: the initial complaint was re-reviewed and found not reportable.Re-reviewed due to information obtained from the investigation.The product was not returned to us customer quality, however an investigation was completed by the courier service.Based on the returned report the white glove process was not completed, which was attributed to human error.There is no product deficiency alleged and the complaint is directly attributed to the delivery status of the sets being left at the receiving dock by the vendor rather than being delivered to sterile processing.The reportability will be updated from si to nr as it has been identified that there was no product allegation and there was no related kit stocking issue.This event was a result of human error from the vendor.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: TEN SYSTEM GRAPHIC CASE
• Common Device Name: TRAY,SURGICAL INSTRUMENT
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7510682
• Report Number: 2939274-2018-52160
• Device Sequence Number: 19238287
• Product Code: FSM
• UDI-Device Identifier: 10886982251954
• UDI-Public: (01)10886982251954
• Combination Product (Y/N): N
• Initial Reporter State: DE
• 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): 02/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 690.109
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/23/2018
• Supplement Date Received by Manufacturer: 08/15/2018
• Initial Report FDA Received Date: 05/14/2018
• Supplement Report FDA Received Date: 08/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention