MAUDE Adverse Event Report: STRYKER TRAUMA KIEL UNKNOWN T2 SCREW EXTRACTOR; INSTRUMENT

Catalog Number UNK_TNE

Device Problems Shipping Damage or Problem (1570); Component Missing (2306)

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

Event Date 08/26/2021

Event Type  Injury  

Manufacturer Narrative

Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Device was missing at the time of surgery.

Event Description

A revision of the surgery performed about a year ago was scheduled due to confirmed postoperative screw fracture.However, before the revision, a mistake in ordering the instruments was discovered and the surgery was postponed.The patient was under general anesthesia.This pi is about a mistake in ordering the instruments additional information: the revision surgery took finally place on (b)(6) 2021.

Event Description

A revision of the surgery performed about a year ago was scheduled due to confirmed postoperative screw fracture.However, before the revision, a mistake in ordering the instruments was discovered and the surgery was postponed.The patient was under general anesthesia.This pi is about a mistake in ordering the instruments.**additional information: the revision surgery took finally place on (b)(6) 2021.

Manufacturer Narrative

Please note correction to h6 device code.The reported event could not be confirmed since the device was not returned for evaluation and no other evidence was provided.A device inspection was not possible since the affected device was not returned, and no other evidence were provided for investigation.The batch record could not be reviewed because the affected device was not returned, and the lot number was not communicated.Through the available information, the alleged issue is identified to be most likely a user related event wherein incorrect instruments were ordered by the user.However, more information is required to thoroughly investigate and determine the root cause of the complaint event.If the device is returned or if any additional information is provided, the investigation will be reassessed.

• Brand Name: UNKNOWN T2 SCREW EXTRACTOR
• Type of Device: INSTRUMENT
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer Contact: marilyne chaumont ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 12488487
• MDR Text Key: 271918742
• Report Number: 0009610622-2021-00696
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK_TNE
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/23/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 89 YR
• Patient Sex: Female
• Patient Race: Asian