MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH 5.5 EXP VERSE SCREW 7.0 X 50; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	199721750
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	06/08/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional procodes: kwp, kwq, mnh, mni, osh.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 or Problem Description
It was reported that during a spinal fusion for a l1 burst fracture on (b)(6) 2020, the surgeon was breaking the tabs off a verse screw and in doing so, a part of the screw was chipped off.The surgeon placed screws in levels t11 l2.Screws were placed successfully.Spinal rods were contoured and placed into the screw heads.Set screws were placed over the rods successfully.Final tightening of the set screws was successful.The surgeon went to break the extended tabs off the screws, and one screw chipped while breaking off a tab.The surgeon then removed the set screw from that verse screw and replaced it with a new screw.The chipped piece of screw was removed.Procedure was completed successfully with a delay of twenty (20) minutes.The patient was not harmed.This report is for a 5.5 exp verse screw 7.0 x 50.This is report 1 of 1 for (b)(4).
Additional 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: the device history record (dhr) of product code 199721750, lot 223239 was reviewed and no non-conformance was observed during the manufacturing process.The product was released on november 10, 2018.Visual inspection: the 5.5 exp verse screw 7.0 x 50 was returned and received at us customer quality (cq).Upon visual inspection, it was observed that the proximal portion of the screw tab on the side of the part/lot number etched is broken and the broken fragment was not returned.No other issues were identified with the returned device.Dimensional inspection: a dimensional inspection was performed on the returned device.The outer diameter of the screw head was measured to be within the specification.The inner diameter of the screw head was measured to be within the specification.Document/specification review based on the date of manufacture, the current and manufactured revision of drawings were reviewed.Expedium verse- 4.35 mm/ 8mm poly screw assembly;expedium verse screw head.Investigation conclusion: the complaint condition is confirmed for the 5.5 exp verse screw 7.0 x 50.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 unintended forces applied to the device.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: 5.5 EXP VERSE SCREW 7.0 X 50
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 10180942
• Report Number: 1526439-2020-01224
• Device Sequence Number: 3083384
• Product Code: NKB
• UDI-Device Identifier: 10705034442099
• UDI-Public: (01)10705034442099
• Combination Product (Y/N): N
• Initial Reporter State: ND
• Initial Reporter Country: US
• PMA/510(K) Number: K142185
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/08/2020

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: 199721750
• Device Catalogue Number: 199721750
• Device Lot Number: 223239
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2020
• Initial Date Received by Manufacturer: 06/08/2020
• Supplement Date Received by Manufacturer: 07/16/2020
• Initial Report FDA Received Date: 06/22/2020
• Supplement Report FDA Received Date: 07/20/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN LOCKING/SET SCREWS; UNKNOWN RODS; UNKNOWN SCREWDRIVERS
• Patient Age: 28 YR