MAUDE Adverse Event Report: DEPUY SYNTHES SPINE ADJUST WEDDING BAND 3.5-5.5; ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION

Catalog Number	188311302
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Not Applicable (3189)
Date of Event	10/27/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Device is being returned 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
Account name: (b)(6) hospital.On (b)(6) 2017, surgery was performed using the mountaineer system.The fixed area was c2 ¿ t4.During the surgery, the following implant got broken when the surgeon tried to place it in the body.Mntr adjust wedding band 3.5-5.5 (part#: 188311302, lot#: ca5bl94).The surgeon dealt with this event by using a spare implant.No broken parts were found left in the body, and the surgery was completed with a 2-minute delay.There was no adverse consequence to the patient.
Additional Manufacturer Narrative
Product complaint # (b)(4).Visual examination found that the mountaineer adjust connector¿s components which include the rod holder and compression chip had fallen apart.Based on the observed failure it is suggested that higher than anticipated forces were placed on the adjust connector, thus resulting in its components falling apart.Therefore, the reported device failure is confirmed based on the evaluation of the returned device.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 trend analysis was conducted.No emerging trends were found requiring further actions.A definitive root cause for the mountaineer adjust connector falling apart cannot be positively determined.However, based on the observed failure it is suggested that higher than anticipated forces were placed on the adjust connector, thus resulting in its components falling apart.No corrective action/preventive action (capa) is necessary at this time as no issues were identified in the manufacturing and release of this device that could have contributed to the problem reported by the customer.Therefore, 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: ADJUST WEDDING BAND 3.5-5.5
• Common Device Name: ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION
• Manufacturer (Section D): DEPUY SYNTHES SPINE; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7069444
• Report Number: 1526439-2017-50006
• Device Sequence Number: 16586788
• Product Code: NKG
• UDI-Device Identifier: 10705034156774
• UDI-Public: 10705034156774
• Combination Product (Y/N): N
• PMA/510(K) Number: K042508
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/27/2017

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: 188311302
• Device Lot Number: CA5BL94
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2017
• Initial Date Received by Manufacturer: 10/27/2017
• Supplement Date Received by Manufacturer: 12/06/2017
• Initial Report FDA Received Date: 11/29/2017
• Supplement Report FDA Received Date: 12/18/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1