MAUDE Adverse Event Report: DEPUY SPINE INC MNTR OC PLATE MEDIUM; ORTHOSIS, SPINAL PEDICLE FIXATION

Catalog Number	188362037
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); Not Applicable (3189)
Date of Event	02/05/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (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
Oc plates broke while bending.Oc plate rod capture was splayed and could not lock a set screw.Additional information received from rep: the first plate had the issue with the splaying of the right rod capture (tulip head).The 2nd and 3rd plates were then broken when trying to contour because we had to remove the first plate.Surgeon completed the case, the event probably delayed the case about 30 minutes.Patient consequence? :no.Is the information being submitted for this complaint all the details that are known/available regarding this event? : yes.
Additional Manufacturer Narrative
Product complaint # (b)(4).Visual examination of the mntr oc plate medium showed slight witness marks which are evidence of usage.The visual inspection also revealed that the plate was broken.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.All complaint trends will be evaluated as a part of the depuy spine monthly complaint review meeting.A definitive root cause for mntr oc plate medium becoming broken cannot be positively determined.However, noted damage suggests that the plate was likely subjected to unanticipated torsional forces during the use, resulting in the breaking of the plate.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 and no systemic trends were found, 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, SPINAL PEDICLE FIXATION
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7297302
• Report Number: 1526439-2018-50174
• Device Sequence Number: 13692446
• Product Code: MNI
• UDI-Device Identifier: 10705034158884
• UDI-Public: 10705034158884
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2018

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 Catalogue Number: 188362037
• Device Lot Number: WA2290
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2018
• Initial Date Received by Manufacturer: 02/06/2018
• Supplement Date Received by Manufacturer: 02/27/2018
• Initial Report FDA Received Date: 02/26/2018
• Supplement Report FDA Received Date: 03/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1