MAUDE Adverse Event Report: STRYKER TRAUMA KIEL UNKNOWN STRIKE PLATE; INSTRUMENT

Catalog Number UNK_KIE

Device Problems Difficult or Delayed Positioning (1157); Failure to Advance (2524)

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

Event Date 07/30/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the strike plate would not thread into targeting device.Procedure was completed successfully with no surgical delay or adverse consequences reported.

Event Description

It was reported that the strike plate would not thread into targeting device.Procedure was completed successfully with no surgical delay or adverse consequences reported.

Manufacturer Narrative

The reported event could not be confirmed, since the device was not returned for evaluation and no other evidence was provided.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.It could not be excluded that the device was pre-damaged in former surgeries but this should have been noticed during pre-op check which is required per ifu.In case the item and / or substantive information will become available in future the investigation will be reviewed and reopened.Device disposition unknown.

• Brand Name: UNKNOWN STRIKE PLATE
• Type of Device: INSTRUMENT
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32
• MDR Report Key: 8922763
• MDR Text Key: 161693185
• Report Number: 0009610622-2019-00621
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 11/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK_KIE
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 69 YR