MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC HOLDING SLEEVE 105MM; GUIDE

Model Number 394.46

Device Problems Device-Device Incompatibility (2919); Appropriate Term/Code Not Available (3191)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/08/2021

Event Type  malfunction  

Manufacturer Narrative

Without a lot number, the device history records review could not be completed as no product was received.The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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 Description

It was reported that on (b)(6) 2021 the surgeon was using a large distractor during a procedure to fix a broken ankle.While tightening the wing screw to secure a 5.0mm schanz screw through the holding sleeve, the wing screw broke in the holding sleeve due to the surgeon tightening too hard using a pin wrench.The case was completed with 1-minute surgical delay.After the case, the broken wing screw fragment and schanz screw were stuck in the holding sleeve and staff were unable to disassemble the items.The surgery was completed with 1 (one) minute delay.The patient outcome was unknown.Concomitant device reported: wing screw (part# 831, lot# unknown, quantity 1).This complaint involves two (2) devices.This report involves one (1) holding sleeve 105mm.This is report 1 of 1 (b)(4).

Event Description

Additional concomitant devices: 5.0mm schanz screw blunted trocar point 200mm (part 294.56, lot 64p5009, quantity 1).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10: additional narrative: b5, d4, d11 h3, h4, h6: part 394.460, lot 22p3333: manufacturing site: bettlach (jabil).Release to warehouse date: october 22, 2019.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.H3, h6: a service and repair evaluation was completed: the repair technician reported the wing nut handle is broken off and the schanz screw is stuck in the shaft.Damaged component is the reason for repair.The cause of the issue is unknown.The following parts were replaced: wing screw.The item was repaired per the inspection sheet, passed synthes final inspection and will be returned to the customer upon completion of the service and repair process.The evaluation was confirmed.The device was deemed serviceable and will be 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.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: HOLDING SLEEVE 105MM
• Type of Device: GUIDE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 11247635
• MDR Text Key: 229630842
• Report Number: 2939274-2021-00539
• Device Sequence Number: 1
• Product Code: FZX
• UDI-Device Identifier: 10886982199744
• UDI-Public: (01)10886982199744
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 394.46
• Device Catalogue Number: 394.46
• Device Lot Number: 4L78926
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2021
• Date Manufacturer Received: 02/17/2021
• Patient Sequence Number: 1
• Treatment: 5.0MM SCHANZ SCREW BLUNTED TROCAR POINT 200MM; UNK - SCHANZ SCREWS; WING SCREW