MAUDE Adverse Event Report: STRYKER GMBH CANNULATED SELF-TAPPING COMPRESSION SCREW FIXOS Ø3.5MM / L36MM; IMPLANT

Catalog Number	CS36A
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/16/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available it will be provided on a supplemental report.
Event or Problem Description
It was reported that two broken cannulated stryker screws were received with the product returned for (b)(4).The rep could not confirm the event that is associated with the broken screws.
Additional Manufacturer Narrative
The reported event that cannulated self-tapping compression screw fixos ø3.5mm / l36mm was alleged of 'breakage during surgery' could be confirmed.Based on investigation, the root cause was attributed to be user related.These are some of the possible causes: insertion of the screw in dense cortical bone without pre-drilling.The operative technique states: ¿[.] the self-drilling and self-tapping tip of the fixos screws is intended for cancellous bone.In dense cortical bone, pre-drilling with cannulated drill ø2.7mm / ø3.5mm (ref (b)(4)) and use of the cannulated tap ø4.0mm / 5.0mm ((b)(4)) is recommended, especially when placing oblique screws.[.]¿ insertion of the screw in dense cortical bone with an inappropriate angle.The operative technique clearly states: ¿contact of fixos screw with dense bone in a tangential direction may cause a deviation of the screw and/or a bending of the k-wire, which may result in damage to the implant.[¿]¿ implant of the screw without a k-wire.The device inspection revealed the following: the body of the screw is largely bent in the middle, and it can be noticed that the broaches normally present at the tip of the screw have been flattened.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.
Event or Problem Description
It was reported that two broken cannulated stryker screws were received with the product returned for (b)(4).The rep could not confirm the event that is associated with the broken screws.

• Brand Name: CANNULATED SELF-TAPPING COMPRESSION SCREW FIXOS Ø3.5MM / L36MM
• Common Device Name: IMPLANT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 6185576
• Report Number: 0008031020-2016-00621
• Device Sequence Number: 1418593
• Product Code: HWC
• UDI-Device Identifier: 07613252259220
• UDI-Public: (01)07613252259220(10)J28958
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K070039
• 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): 01/20/2017

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: CS36A
• Device Lot Number: J28956
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/21/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/19/2016
• Supplement Report FDA Received Date: 01/20/2017
• 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: Other