MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC PROACCESS(TM) VERTICAL MAST; RETRACTOR

Model Number 03.612.001

Device Problem Mechanical Problem (1384)

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

Event Type  malfunction  

Manufacturer Narrative

Reporter is a synthes employee.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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 an unknown date during an unknown procedure the set screw in the minimally invasive surgery (mis) proaccess vertical mast was no longer fixed to the clamp.The set screw spun when tightening the clamp thus allowing the unknown rod to slide through the clamp and it would not tighten properly.It is unknown if the procedure was completed successfully.It is unknown if there was a surgical delay.There was no patient consequence reported.Concomitant device reported: unknown rod (part# unknown, lot# unknown, quantity 1).This report is for 1 proaccess(tm) vertical mast.This is report 1 of 1 for (b)(4).

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: h3, h4, h6: part 03.612.001, lot 1428826: manufacturing site: hägendorf.Release to warehouse date: january 23, 2006.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.H3, h6: a product investigation was completed: upon visual inspection, the device doesn¿t show any visual damage except normal wear on the surface of the components of the device.The device was unable to tighten and clamp grip slides on the mast tube when some force is applied.Thus, confirming the complaint.A functional test cannot be performed due to loosen coupling sliding on the tube when some force was applied.The dimension that is potentially relevant to the complaint condition is the outer diameter of the tube.The outer diameter was measured to be within the specification.Based on the date of manufacture, the current and manufactured revision of drawings were reviewed.The complaint condition was confirmed.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.The potential cause could be due to repeated reprocessing and sterilization cycles over 14 years of use in the field, causing the clamp grip worn out leading to loosening of coupling.Based on the investigation findings, it has been determined that 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 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: PROACCESS(TM) VERTICAL MAST
• Type of Device: RETRACTOR
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 11006717
• MDR Text Key: 222309545
• Report Number: 2939274-2020-05574
• Device Sequence Number: 1
• Product Code: GAD
• UDI-Device Identifier: 10705034714462
• UDI-Public: 10705034714462
• 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
• Type of Report: Initial,Followup
• Report Date: 11/17/2020

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
• Device Operator: Health Professional
• Device Model Number: 03.612.001
• Device Catalogue Number: 03.612.001
• Device Lot Number: 1428826
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2020
• Initial Date Manufacturer Received: 11/17/2020
• Initial Date FDA Received: 12/15/2020
• Supplement Dates Manufacturer Received: 12/30/2020
• Supplement Dates FDA Received: 01/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNK - RODS