MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC HOLDING SLEEVE; SCREWDRIVERS

Model Number	313.97
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device used in a veterinary case - no patient information will be reported.Device is an instrument and is not implanted/explanted.Dhr review was completed.Please note, lot number 1849625 indicates part 313.940 which is the complete part including 313.970.Part: 313.940 , lot: 1849625.Manufacturing site: (b)(4).Release to warehouse date: 20.Mar.2008.The device history record shows this lot of 24 pieces was processed through the normal manufacturing and inspection operations with no rework or nonconformities noted.This lot met all dimensional, visual and functional criteria at the time of release with no issues documented during the manufacturing process.Review of the device history record showed that there were no issues during the manufacture of this product which would contribute to this complaint condition.Service & repair evaluated the returned device.Service & repair evaluation the customer reported the holding sleeve was not working properly.The repair technician reported the spring was missing.Missing parts is the reason for repair.The cause of the issue is unknown.The following parts were replaced: spring.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.Finalized service record will be archived in 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, 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
This report is for a veterinary case.There was no human patient involvement.It was reported that on an unknown date the holding sleeve was not functioning properly.There was no patient involvement.This report is for one (1) holding sleeve.This is report 1 of 1 for (b)(4).

• Brand Name: HOLDING SLEEVE
• Common Device Name: SCREWDRIVERS
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7824461
• Report Number: 2939274-2018-53524
• Device Sequence Number: 16423164
• Product Code: HXX
• UDI-Device Identifier: 10887587037196
• UDI-Public: (01)10887587037196
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/29/2018

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: 313.97
• Device Catalogue Number: 313.97
• Device Lot Number: 1849625
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/28/2018
• Initial Report FDA Received Date: 08/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1