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

Model Number	314.08
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported the holding sleeve was missing a piece the repair technician reported the cap of the sleeve was missing and epoxy was missing from the inner shaft.Missing parts is the reason for repair.The item is not repairable per the inspection sheet.The cause of the issue is unknown.The item will be forwarded to customer quality.The evaluation was confirmed.Holding sleeve (part# 314.08, lot# 6740569) was returned received at us cq.Upon visual inspection at cq, it is observed that the device was missing a component, coupling sleeve.The epoxy markings (orange) on the received components were started to peel off.Thus, the complaint is being confirmed.The complaint is being confirmed for holding sleeve (part# 314.08, lot# 6740569) as the device was missing coupling sleeve.Coupling sleeve of the device might have got misplaced during sterilization process.No product design or manufacturing issues were identified, and no new malfunctions were identified either.Based upon these results, no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Device history lot part #: 314.08, synthes lot #: 6740569, manufacturing site: synthes (b)(4), release to warehouse date: 08-aug-2011.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.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 on an unknown date, during routine incoming inspection of a loan set, it was observed that the holding sleeve was missing a piece.There was no known patient or hospital 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: SCREWDRIVER
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10741375
• Report Number: 2939274-2020-04834
• Device Sequence Number: 14238252
• Product Code: HXX
• UDI-Device Identifier: 10886982188472
• UDI-Public: (01)10886982188472
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/29/2020

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: 314.08
• Device Catalogue Number: 314.08
• Device Lot Number: 6740569
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/29/2020
• Initial Report FDA Received Date: 10/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1