MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH 5.5 EXP VERSE CAN SCR 6.0X50; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Catalog Number 199725650S

Device Problem Break (1069)

Patient Problems Non-union Bone Fracture (2369); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Additional procode: kwp; kwq; mnh; mni; osh.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.(b)(4).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 Description

Device report from synthes reports an event in (b)(6) as follows: on (b)(6) 2018, the primary procedure with verse screws was performed to treat fracture.On (b)(6) 2020, a removal procedure was performed.The surgeon found that the screws had broken off.He decided to leave fragments in the patient¿s body for the following reasons: the fragments were located deep in the lesion.He assessed that fragments would not cause adverse effect to the patient.He commented the following: bone healing was not completed, so extra loading might have been put to the broken screws.Metal fatigue might have triggered the event.This report is for one (1) 5.5 exp verse can scr 6.0x50.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: updated data: d6 - implant date and explant date.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.

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.The dhr of product code 199725650s, lot 151930, was reviewed and no non-conformance was observed during the manufacturing process.The product was released on september 28, 2017.Qty.(b)(4).The dhr was electronically reviewed.Visual inspection: the 5.5 exp verse can scr 6.0x50 (p/n: 199725650, lot number: 151930) was received at us cq.Visual inspection of the complaint device showed that the screw was broken at the middle of the quad lead threads.No x-rays or other photographs were provided.Device failure/defect identified? yes.Dimensional inspection: the dimensional inspection was not performed as the complaint relevant dimensions cannot be checked for dimensional accuracy due to post-manufacturing damage.Document/specification review: the following drawings reflecting the current and manufactured revisions were reviewed: expedium verse 5.5 system cortical fix cannulated assembly.No design issues or discrepancies were identified.Complaint confirmed? yes.Investigation conclusion: the complaint was confirmed for the received 5.5 exp verse can scr 6.0x50 (p/n: 199725650, lot number: 151930) as the screw was broken at the middle of the quad lead threads.While no definitive root cause could be determined based on the provided information, it is possible that the device was encountered unintended loading.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 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 CAN SCR 6.0X50
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 10764449
• MDR Text Key: 214093512
• Report Number: 1526439-2020-02067
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10705034440774
• UDI-Public: (01)10705034440774
• Combination Product (y/n): N
• PMA/PMN Number: K142185
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 10/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2022
• Device Catalogue Number: 199725650S
• Device Lot Number: 151930
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2020
• Date Manufacturer Received: 12/08/2020
• Patient Sequence Number: 1
• Treatment: 5.5 EXP VERSE CAN SCR 6.0X50.; UNKNOWN LOCKING/SET SCREWS.; UNKNOWN RODS.
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR