MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC HOOK OR SCREW HOLDER; LXH

Model Number	388.61
Medical Device Problem Codes	Device-Device Incompatibility (2919); Mechanical Jam (2983)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.Product was not returned.Based on the information available, it has been determined that no corrective and/ or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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 (b)(6) 2020, during a routine inspection of consignment sets the following uss handles for hook or screw holder were found to be not functioning properly.The gray top of the handle does not turn the "implant holder".They believe that the set screw on the gray knob of the handle for hook or screw holder is not adequately engaging in the inner shaft of the instrument.The reporter referred to implant holder was the screw holder.The inner shaft is an internal part in the handle for hook or screw holder.There was no patient involvement.Concomitant device reported: uss hook and screw holder (part # 388.610, lot # unknown, quantity 1).This report is for one (1) hook or screw holder.This is report 1 of 1 for (b)(4).

• Brand Name: HOOK OR SCREW HOLDER
• Common Device Name: LXH
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10451251
• Report Number: 2939274-2020-03794
• Device Sequence Number: 3960428
• Product Code: LXH
• UDI-Device Identifier: 10705034773612
• UDI-Public: 10705034773612
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/30/2020

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: 388.61
• Device Catalogue Number: 388.61
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/30/2020
• Initial Report FDA Received Date: 08/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1