MAUDE Adverse Event Report: STRYKER GMBH CANCELLOUS SCREW Ø4.0X40MM TL14MM; PLATE, FIXATION, BONE

Catalog Number 604240S

Device Problem Detachment Of Device Component (1104)

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

Event Date 05/22/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The surgeon reported that he inserted two screws through the cross part of the t plate into the prepared holes which had been drilled using a 2.5mm drill.As he turned the patient's foot the two screws, one partially threaded cancellous and one fully threaded cancellous, fell out of the plate.The surgeon had been using a 2.5mm drill and inserted 4mm diameter screws.He reported that he did not feel any purchase when the screws were put into the patient.The thread of the screws that fell out looked intact and functional.There was nothing remarkable about bone quality.The surgeon completed the case using a smaller diameter drill bit and inserted all fully threaded screws through the plate.There was a 30 minute delay.

Event Description

The surgeon reported that he inserted two screws through the cross part of the t plate into the prepared holes which had been drilled using a 2.5mm drill.As he turned the patient's foot the two screws, one partially threaded cancellous and one fully threaded cancellous, fell out of the plate.The surgeon had been using a 2.5mm drill and inserted 4mm diameter screws.He reported that he did not feel any purchase when the screws were put into the patient.The thread of the screws that fell out looked intact and functional.There was nothing remarkable about bone quality.The surgeon completed the case using a smaller diameter drill bit and inserted all fully threaded screws through the plate.There was a 30 minute delay.

Manufacturer Narrative

The reported event that cancellous screw ø4.0x40mm tl14mm was alleged of issue (poor fixation) could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.A device inspection was not possible since the affected device was not returned and no other evidences were provided for investigation.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of manufacturing or design related problems were found during the investigation.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.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.

• Brand Name: CANCELLOUS SCREW Ø4.0X40MM TL14MM
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 7584295
• MDR Text Key: 110873436
• Report Number: 0008031020-2018-00454
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• PMA/PMN Number: K972323
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 11/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2020
• Device Catalogue Number: 604240S
• Device Lot Number: J31485
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other