MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH 5.5 TI CORT FIX 6X50MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number 186731650

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Device deemed reportable during investigation.Reporter is company representative.Investigation summary: investigation was performed at manufacturing site in (b)(4).Visual inspection: 5.5 ti cort fix 6x50mm (qty: 1) was received at us cq and sent to manufacturer (b)(4).Upon visual inspection, it is observed that polyaxial cap of device was received fell apart.The swaging marks deformation on the head that indicate the swaging has been done during assembly step.No other physical damage except normal wear was observed with the device.Thus, the complaint is being confirmed.Functional test: functional inspection of the received device was not performed at cq due to the received condition of the device.Can the complaint be replicated with the returned device? unable to perform.Dimensional inspection: dimensional inspection was performed by manufacturer in (b)(4).Outer diameter of the polyaxial cap was intended to be measuring from 7.436mm to 7.487mm and it was measured to be 7.468mm.Internal diameter of the head was intended to be measuring from 7.535mm to 7.565mm and it was measured to be 7.54mm.The thickness of the wall 0.19mm +/-0.05mm has not been dimensionally checked as there is a deformation in the swaged area for all three devices.All the dimensions are within specification as per the drawings.Documentation/ specification review: the following drawing(s) was reviewed; vertical ti cortical fix cannulated screw assy, expedium 5.5 rod system polyaxial cap 7.5mm screw, expedium 5.50 ti rod system 7.50 polyaxial screw head.No design issues or discrepancies were found during this investigation.Complaint confirmed? yes.Investigation conclusion: visual inspection, dimensional inspection, and document specification review of the received device was performed.The complaint is being confirmed as the polyaxial cap of device was received fell apart.A definitive root cause could not be determined for the reported problem.During the investigation no unidentified product design/manufacturing issues or discrepancies were observed that may have contributed to the complaint condition.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 history: part # 186731650, lot # 251027.The product was released on july 19th, 2019.Qty.(b)(4).The devices were 100% inspected for proper swaging during manufacturing.No non-conformances were identified during dhr review.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 a routine incoming inspection of a loaner set, it was observed that several 5.5 mm ti cort fix 6x50mm were damaged.There was no known patient or hospital involvement.This is report 3 of 3 for (b)(4).

• Brand Name: 5.5 TI CORT FIX 6X50MM
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer (Section G): BRIDGEWATER DISTRIBUTION; 50 scotland boulevard; bridgewater MA
• Manufacturer Contact: kara ditty-bovard ; chemin-blanc 38; le locle 02400 ; SZ 02400 ; 6103142063
• MDR Report Key: 10025221
• MDR Text Key: 225247169
• Report Number: 1526439-2020-00932
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10705034351841
• UDI-Public: (01)10705034351841
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160904
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 186731650
• Device Catalogue Number: 186731650
• Device Lot Number: 251027
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/05/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/19/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1