MAUDE Adverse Event Report: STRYKER SPINE-US ACP 1 VARIABLE SELF DRILLING BONE SCREW SET DIA 4.0X16MM; SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS

Model Number	2110-0039
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Information (3190)
Date of Event	10/30/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; locking screw broke in plate.Update 10/31/2017: event occured during surgery.
Additional Manufacturer Narrative
Medical products: catalog# 48804316a, lot# m-61282.Method: visual inspection;device history review; complaint history review; risk assessment; results: manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.Conclusion: the probable root cause is lack of preparation of the screw hole as recommended by the stg.
Event or Problem Description
It was reported that; locking screw broke in plate.Update 10/31/2017: event occured during surgery.

• Brand Name: ACP 1 VARIABLE SELF DRILLING BONE SCREW SET DIA 4.0X16MM
• Common Device Name: SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 7049722
• Report Number: 3004024955-2017-00040
• Device Sequence Number: 10991166
• Product Code: KWQ
• UDI-Device Identifier: 00808232001372
• UDI-Public: (01)00808232001372
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K150700
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/23/2018

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: No Information
• Device Model Number: 2110-0039
• Device Catalogue Number: 48804316A
• Device Lot Number: M-61282
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2017
• Initial Date Received by Manufacturer: 10/30/2017
• Supplement Date Received by Manufacturer: 10/30/2017
• Initial Report FDA Received Date: 11/21/2017
• Supplement Report FDA Received Date: 01/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 55 YR