MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH 5.5 EXP VERSE FEN SCR 6.0X50; BONE CEMENT, POSTERIOR SCREW AUGMENTATION

Model Number	199723650
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/16/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 germany reports an event as follows: it was reported that on (b)(6) 2021 that the verse correction key interlocked with the screw placed at the left sided l5 and broke due to the interlocking.The thread of the screw also broke as a result and had to be removed and exchanged.A metal chip was removed during removal.The same thing happened on the right side but the screw did not break and remained in the patient.The verse correction key was removed and exchanged four (4) times during the procedure and one (1) screw was replaced during the procedure.This resulted in an twenty (20) minute delay.This report is for one (1) 5.5 exp verse fen scr 6.0x50.This is report 5 of 6 for pc (b)(4).
Additional Manufacturer Narrative
Product complaint # (b)(4).Depuy synthese is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthese has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthese or its employees that the report constitutes an admission that the device, depuy synthese, or its employees caused or contributed to the potential event described in this report.H4: manufacturing date updated.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.
Additional Manufacturer Narrative
Product complaint # (b)(4).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.Investigation flow: damage.Visual inspection: upon visual inspection no damage was noted on the implant that would contribute to the complaint condition.Nothing is broken with the screw.A device failure was not identified.Dimensional inspection: no dimensional inspection was performed as no issues were noted with implant.Document/specification review: based on the review of the above drawings, no design issues contributing to relevant complaint condition were identified.Investigation conclusion: there is no indication that a design or manufacturing issue contributed to the complaint as it was unconfirmed.No new malfunctions were observed during this investigation (based on the images) that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Device history lot.Part number: 199723650.Lot number: 261833.Device history review: the dhr of product code 199723650, lot 261833, was reviewed and no non-conformances were observed during the manufacturing process.The product was released on november 9, 2019.Qty.(b)(4).The dhr was electronically reviewed.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 FEN SCR 6.0X50
• Common Device Name: BONE CEMENT, POSTERIOR SCREW AUGMENTATION
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 11496398
• Report Number: 1526439-2021-00459
• Device Sequence Number: 14577332
• Product Code: PML
• UDI-Device Identifier: 10705034403076
• UDI-Public: 10705034403076
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/16/2021

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: 199723650
• Device Catalogue Number: 199723650
• Device Lot Number: 261833
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2021
• Initial Date Received by Manufacturer: 02/16/2021
• Supplement Date Received by Manufacturer: 04/15/2021; 04/30/2021
• Initial Report FDA Received Date: 03/16/2021
• Supplement Report FDA Received Date: 04/27/2021; 05/13/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 5.5 EXP VERSE FEN SCR 6.0X50; VERSE CORRECTION KEY; VERSE CORRECTION KEY; VERSE CORRECTION KEY; VERSE CORRECTION KEY