MAUDE Adverse Event Report: STRYKER TRAUMA KIEL UNKNOWN TS2GA LOANER SET; IMPLANT

Catalog Number UNK_KIE

Device Problem Component Missing (2306)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/17/2021

Event Type  malfunction  

Manufacturer Narrative

Upon completion of the investigation any additional information will be communicated in a supplemental report.

Event Description

It was reported the patient was already under anesthesia and then it was noticed that the basic box was delivered twice and the sga box add on was missing.The delivery note and the labelling of the box was correct, the contents were missing.This resulted in unnecessary anesthesia, prolonged hospitalization and rescheduling of the operation.

Event Description

It was reported the patient was already under anesthesia and then it was noticed that the basic box was delivered twice and the sga box add on was missing.The delivery note and the labelling of the box was correct, the contents were missing.This resulted in unnecessary anesthesia, prolonged hospitalization and rescheduling of the operation.

Manufacturer Narrative

The reported event could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.The device inspection was not possible as the product was not returned for investigation.The device history record could not be reviewed because the affected device was not returned, and the lot number was not communicated.A review of the labeling did not indicate any abnormalities.The instructions for use instructs user that: ¿before the surgical procedure, ensure that all components prepared for the procedure function correctly with each other.¿ 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.However, a nonconformance at the distribution site has been raised to avoid these cases in future.If device is returned or any further information is provided, the investigation report will be reassessed.

• Brand Name: UNKNOWN TS2GA LOANER SET
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• MDR Report Key: 12161035
• MDR Text Key: 263456284
• Report Number: 0009610622-2021-00591
• Device Sequence Number: 1
• Product Code: HSB
• 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: 09/22/2021

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
• Device Operator: Health Professional
• Device Catalogue Number: UNK_KIE
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/17/2021
• Initial Date FDA Received: 07/13/2021
• Supplement Dates Manufacturer Received: 09/07/2021
• Supplement Dates FDA Received: 09/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1