MAUDE Adverse Event Report: STRYKER GMBH ANCHORAGE SCREW; IMPLANT

Catalog Number UNK_SEL

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/27/2016

Event Type  malfunction  

Manufacturer Narrative

Once the investigation has been completed any additional information will be reported in a supplemental report.

Event Description

It was reported by the distribution manager that the screw went through the plate during surgery so another plate and screw was used to complete the surgery.No complications or delay.

Manufacturer Narrative

The reported incident that an unknown anchorage screw was alleged of issue s-41 (poor fixation) could be confirmed since this is a known design issue.The root cause of this positioning issue has been identified as a design issue.The nc 565281 has been opened for recurring issue.The threshold defined in the risk management file was not exceeded.Design improvement actions were identified in capa (b)(4).Design improvements consist in changing tolerances of the screw head in order to strengthen the connectivity between plate and screws.A review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.If the device is returned or if any additional information is provided, the investigation will be reassessed.Device was not returned.

Event Description

It was reported by the distribution manager that the screw went through the plate during surgery so another plate and screw was used to complete the surgery.No complications or delay.

• Brand Name: ANCHORAGE SCREW
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• Manufacturer (Section G): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• Manufacturer Contact: rose haas ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5458363
• MDR Text Key: 39330858
• Report Number: 0008031020-2016-00081
• Device Sequence Number: 1
• Product Code: OAT
• Combination Product (y/n): N
• Reporter Country Code: ZA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNK_SEL
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/25/2016
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other