MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH MNTR LS SCREW 3.5X28; ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION

Model Number	188320328
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Failure of Implant (1924); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional device product codes: kwp and mni.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.(b)(4).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 synthes reports an event in (b)(6) as follows: it was reported that on an unknown date that the patient underwent a revision surgery for the removal of mountaineer screws.No fragments were generated.There were no patient consequences.The revision surgery was completed successfully.Concomitant devices reported: mntr ls screw 3.5x28 (part number 188320328, lot atnbnv, quantity 1), rod (part number unknown, lot unknown, quantity 2), setscrews (part number unknown, lot unknown, quantity 2).This report involves one (1) mntr ls screw 3.5x28.This is report 2 of 2 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.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
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 mntr ls screw 3.5x28 was not returned, and the investigation will be completed based on the supplied images from the attachments.The images were reviewed, and the complaint condition was confirmed as the image showed the screw shank broken.As the screw was not returned an as received, dimensional, and material review were not applicable.Conclusion the overall complaint was confirmed.No definitive root cause was able to be determined as the circumstances surrounding the event are unknown.During the investigation no unidentified product design/manufacturing issues or discrepancies were observed (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 the dhr of product code 188320328, lot atnbnv, was reviewed and no non-conformance was observed during the manufacturing process.The product was released on (b)(6) 2015.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.
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.H3, h6: 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.
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.H10 additional narrative: b5: updated event description.H3, h6: a product investigation was conducted: investigation flow: damage.Visual inspection: the mntr ls screw 3.5x28 (part #: 188320328, lot #: atnbnv) was received at us cq as an assembly.Upon visual inspection, the screw was broken at the proximal shaft at the beginning of the thread profile.The broken piece was not returned with the reminder device.Device failure/defect identified? yes.Document/specification review: no design issues or discrepancies were identified.Complaint confirmed? yes.Investigation conclusion: this complaint is confirmed as the device mntr ls screw 3.5x28 (part #: 188320328, lot #: atnbnv) was received with broken screw.No definitive root cause could be determined based on the provided information.No new, unique or different patient harms were identified as a result of this evaluation.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 preventive 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: the dhr of product code 188320328, lot atnbnv, was reviewed and no non-conformance was observed during the manufacturing process.The product was released on november 9, 2015.Qty:(b)(4).The dhr was electronically reviewed.,the dhr of product code 188320328, lot atnbnv, was reviewed and no non-conformance was observed during the manufacturing process.The product was released on november 9, 2015.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.
Event or Problem Description
Updated event description: concomitant device reported: unknown set screw (part#: unknown, lot number: 251612, quantity:(b)(4).Unknown set screw (part#: unknown, lot number: 257361, quantity:(b)(4).Mountaineer oct spinal system mini polyaxial bone screw 3.5 x 3.5 x 18mm (part#:188318318, lot number: 214475, quantity:(b)(4).Mountaineer oct spinal system mini polyaxial bone screw 3.5 x 3.5 x 16mm (part#:188318316, lot number: 220105, quantity:(b)(4).Mountaineer oct spinal system rod 3.5 x 60mm (part#:188316060, lot number: bdme3vj, quantity:(b)(4).This complaint involves two (2) devices.

• Brand Name: MNTR LS SCREW 3.5X28
• Common Device Name: ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 10448546
• Report Number: 1526439-2020-01523
• Device Sequence Number: 17033696
• Product Code: NKG
• UDI-Device Identifier: 10705034158129
• UDI-Public: (01)10705034158129
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K190895
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 07/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 188320328
• Device Catalogue Number: 188320328
• Device Lot Number: ATNBNV
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2020
• Initial Date Received by Manufacturer: 07/29/2020
• Supplement Date Received by Manufacturer: 09/15/2020; 09/25/2020; 10/07/2020; 10/19/2020
• Initial Report FDA Received Date: 08/25/2020
• Supplement Report FDA Received Date: 09/16/2020; 09/30/2020; 10/08/2020; 10/20/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MNTR LS SCREW 3.5X28; UNKNOWN LOCKING/SET SCREWS; UNKNOWN RODS; MNTR LS SCREW 3.5X28; UNKNOWN LOCKING/SET SCREWS; UNKNOWN RODS
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 66