MAUDE Adverse Event Report: STRYKER GMBH UNKNOWN SCREW; IMPLANT

Catalog Number UNK_SEL

Device Problems Loose or Intermittent Connection (1371); Mechanical Problem (1384); Positioning Problem (3009)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 08/28/2019

Event Type  malfunction  

Manufacturer Narrative

Upon completion of investigation, additional information will be provided in a supplemental report.

Event Description

As reported: "during surgery, the locking screw did not lock to the plate.The screw was exchanged to a new one, but the situation was not changed.Because the hole of the plate was looked clearly bigger than the other holes and a debris was found, the plate was also exchanged to a new one.The procedure was finished without other problem." no surgical delay or adverse consequences were reported.

Manufacturer Narrative

The reported event could not be confirmed, since the device was not returned for evaluation and no other evidence was provided despite multiple attempts.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 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.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 disposition is unknown.

Event Description

As reported: "during surgery, the locking screw did not lock to the plate.The screw was exchanged to a new one, but the situation was not changed.Because the hole of the plate was looked clearly bigger than the other holes and a debris was found, the plate was also exchanged to a new one.The procedure was finished without other problem." no surgical delay or adverse consequences were reported.

• Brand Name: UNKNOWN SCREW
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 9099636
• MDR Text Key: 193131265
• Report Number: 0008031020-2019-01294
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 12/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK_SEL
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1