MAUDE Adverse Event Report: STRYKER GMBH CANNULATED SCREW ASNIS III Ø4.0X70MM TL23.5MM; SCREW, FIXATION, BONE

Model Number	325070S
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/14/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
After the installation, the end of the screw has disintegrated.Initial surgery on (b)(6) 2017.Revision surgery on (b)(6) 2017.According to the rep, the end of the screw has backed out, it is unknown at this stage if the screw broke.
Additional Manufacturer Narrative
The reported event that a cannulated screw asnis iii ø4.0x70mm tl23.5mm backed out after surgery could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.More detailed information about the complaint event as well as the affected device must be available in order to determine the precise root cause of the complaint event.Loosening of interfragmentary screws resulting in back out is a common problem, especially in osteoporotic bones.Therefore, the most likely cause of the reported event is that the patient had this bone disease, which led to inadequate fixation of the device.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If the device is returned or if any additional information is provided, the investigation will be reassessed.Device was not received.
Event or Problem Description
After the installation, the end of the screw has disintegrated.Initial surgery on (b)(6) 2017.Revision surgery on (b)(6) 2017.According to the rep, the end of the screw has backed out, it is unknown at this stage if the screw broke.

• Brand Name: CANNULATED SCREW ASNIS III Ø4.0X70MM TL23.5MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 6457976
• Report Number: 0008031020-2017-00193
• Device Sequence Number: 693925
• Product Code: HWC
• UDI-Device Identifier: 07613327076257
• UDI-Public: (01)07613327076257(17)211130(10)V44158
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K000080
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 07/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 11/30/2021
• Device Model Number: 325070S
• Device Catalogue Number: 325070S
• Device Lot Number: V44158
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/09/2017
• Supplement Date Received by Manufacturer: 06/16/2017
• Initial Report FDA Received Date: 04/04/2017
• Supplement Report FDA Received Date: 07/12/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention