MAUDE Adverse Event Report: DEPUY-SYNTHES SPINE INNER SCREW; APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Model Number	188362025
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/23/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Lot unknown.Awaiting sample: a follow up report will be filed upon completion of the investigation.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Device not yet returned for evaluation.
Event or Problem Description
It was reported that during final tightening of occipital plate the set screws would not lock in and appeared to be cross threaded.Several set screws were tried, in the end a new 31mm plate, set screws and final tightener were used and the case was able to be completed.
Additional Manufacturer Narrative
Visual examination of the returned device found the threads were torn off.A review of the device history records 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 threads being torn cannot be positively determined.A potential root cause may be due to inadvertently cross-threading the set screw with the screw on the plate during the insertion.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: INNER SCREW
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERLAMINAL
• Manufacturer (Section D): DEPUY-SYNTHES SPINE; 325 paramount drive; raynham MA 02767
• MDR Report Key: 6768803
• Report Number: 1526439-2017-10637
• Device Sequence Number: 2064685
• Product Code: KWP
• UDI-Device Identifier: 10705034158853
• UDI-Public: (01)10705034158853
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K151885
• 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): 07/23/2017

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: Physician
• Device Model Number: 188362025
• Device Catalogue Number: 188362025
• Device Lot Number: BDK53W2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2017
• Initial Date Received by Manufacturer: 07/23/2017
• Supplement Date Received by Manufacturer: 08/25/2017
• Initial Report FDA Received Date: 08/04/2017
• Supplement Report FDA Received Date: 08/25/2017
• Patient Sequence Number: 1