MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH EXPEDIUM VERSE SPINE SYS FEN CORT POLY SCRW 5.5 6.0 X 40MM; ORTHOSIS, SPINAL PEDICLE FIXATION

Model Number	199723640
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/25/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter is synthes sales representative.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
Device report from (b)(6) reports an event as follows: it was reported that on (b)(6) 2021 that the inserter could not be entered correctly into the correction key and slipped during the final tightening.This damaged the thread of the screw head.There was a surgical delay of 30 minutes.The procedure was completed successfully with replacement screw and set screws.This report is for one (1) expedium verse spine system fenestrated cortical fix polyaxial screw 5.5 6.0 x 40mm.This is report 15 of 15 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: updated data: h4.Investigation summary: visual inspection: the 5.5 exp verse fen scr 6.0x40 (part # 199723640, lot # 244128) was received at us cq.Upon visual inspection at cq, it is observed that the device's reduction tabs were broken and received at cq.The device was stripped and showed discoloration.No other issues were identified with the returned device.Device failure/ defect identified? yes.Dimensional inspection: no dimensional inspection can be performed due to post-manufacturing damage.Furthermore, the complaint-relevant dimensions cannot be checked for dimensional accuracy, because of the design of the device.Documentation/ specification review: the drawing(s) was reviewed; no design issues or discrepancies were found during this investigation.Complaint confirmed? yes.Investigation conclusion: the complaint could not be confirmed for the received device.No definitive root cause can be determined based on the provided information.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.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 lot product code: 199723640.Lot number: 244128.The dhr of product code: 199723640, lot: 244128 was electronically reviewed and no non-conformances were observed during the manufacturing process.The product was released on: (b)(6) 2019.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.Corrected data: d9, h3, h6.

• Brand Name: EXPEDIUM VERSE SPINE SYS FEN CORT POLY SCRW 5.5 6.0 X 40MM
• Common Device Name: ORTHOSIS, SPINAL PEDICLE FIXATION
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 12335906
• Report Number: 1526439-2021-01719
• Device Sequence Number: 4686815
• Product Code: MNI
• UDI-Device Identifier: 10705034403090
• UDI-Public: (01)10705034403090
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K160879
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2021

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: 199723640
• Device Catalogue Number: 199723640
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2021
• Initial Date Received by Manufacturer: 07/19/2021
• Supplement Date Received by Manufacturer: 08/23/2021
• Initial Report FDA Received Date: 08/18/2021
• Supplement Report FDA Received Date: 09/10/2021
• Patient Sequence Number: 1