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

Model Number	188362037
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/22/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Device is available for evaluation.Investigation will be conducted.Follow up will be filed with the investigation results.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
It was reported that on (b)(6) 2019, on an unknown procedure, when bending plate snapped at the wing with little force applied.There was a 5 minute surgical delay.Procedure outcome and patient consequence are unknown.This complaint involves one (1) device.
Additional Manufacturer Narrative
Product complaint # (b)(4).Udi: (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.Visual examination of the device revealed that the plate had broken at one of the wings.The second half of the broken end of the device was also returned.The fracture analysis report reveals uniform rough morphology of the fractured surface indicating that the instrument underwent a static failure.A review of the device history record was conducted.No issues were identified during the manufacturing and release of this product that could have contributed to the problem reported by the customer.A definitive root cause for the device¿s wing fracturing cannot be positively determined.However, the fracture analysis report reveals uniform rough morphology of the fractured surface indicating that the instrument underwent a static failure due to a single, sudden, unexpectedly high force placed on the wing of the device.As there has been no issue identified in the manufacturing or release of the device that could have contributed to the problem reported by the customer, this complaint file will be closed with no further action required.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 MEDIUM
• 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: 8700728
• Report Number: 1526439-2019-51763
• Device Sequence Number: 1831832
• Product Code: NKG
• UDI-Device Identifier: 10705034158884
• UDI-Public: (01)10705034158884
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K042508
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/22/2019

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: 188362037
• Device Catalogue Number: 188362037
• Device Lot Number: WA23309
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2019
• Initial Date Received by Manufacturer: 05/22/2019
• Supplement Date Received by Manufacturer: 07/16/2019
• Initial Report FDA Received Date: 06/14/2019
• Supplement Report FDA Received Date: 07/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR