MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH MNTR OC PLATE SMALL; ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION

Model Number	188362031
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/04/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been 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
Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2020, during spinal fusion procedure, the surgeon tried to bend the plate gradually with a bender as per the surgical instruction.The sales rep advised the surgeon not to bend the plate over 15 degrees, but the plate broke off.There was no surgical delay.Patient status is stable.No further information is available.Concomitant device reported: bender (part# unknown, lot# unknown, quantity unknown).This report is for one (1) mntr oc plate small.This is report 1 of 1 for complaint (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.Corrected data: h3, h6.Investigation summary.Visual inspection: a mntr oc plate small (p/n: 188362031, lot #: wa25122) was returned and received at us customer quality (cq).Upon visual inspection, it was observed that the mountaineer oc plate was broken near the bent location and the broken fragment was not returned.No other issues were identified with the returned components of the device.Device failure/defect identified? yes.Dimensional inspection: a dimensional inspection was performed on the returned device.- the thickness of the device 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.- mountaineer occipital plate assembly.- mountaineer occipital plate innie yoke.- mountaineer occipital plate, small.- mountaineer oct spinal system surgical technique, cr17-20-002 4/10 jc/um.Complaint confirmed? yes, the device received was broken.Hence confirming the allegation.Investigation conclusion.The complaint condition was confirmed for the mntr oc plate small (p/n: 188362031, lot #: wa25122).There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.The patterns of fracture do not indicate a probable cause of failure but could be due to overbending of the plate as the mountaineer oct spinal system surgical technique, cr17-20-002 4/10 jc/um (step 12, figure 12b) has mentioned that the oc plate can be bent to a maximum of 15 degree in either direction.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.A review of the receiving inspection (ri) for mntr oc plate small was conducted identifying that lot number wa25122 was released in a single batch.- batch1: lot was released on nov 4, 2019 with no discrepancies.As a result, the ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.Device history review.The ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.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: MNTR OC PLATE SMALL
• 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: 10603320
• Report Number: 1526439-2020-01828
• Device Sequence Number: 11667643
• Product Code: NKG
• UDI-Device Identifier: 10705034158877
• UDI-Public: (01)10705034158877
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K190895
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/04/2020

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: 188362031
• Device Catalogue Number: 188362031
• Device Lot Number: WA25122
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2020
• Initial Date Received by Manufacturer: 09/04/2020
• Supplement Date Received by Manufacturer: 10/23/2020
• Initial Report FDA Received Date: 09/29/2020
• Supplement Report FDA Received Date: 11/04/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN BENDING INSTRUMENTS.