MAUDE Adverse Event Report: STRYKER GMBH SPREADING RECON LAG SCREWDRIVER BIT IMN INSTRUMENTS

Catalog Number 23510220

Device Problem Shipping Damage or Problem (1570)

Patient Problem Insufficient Information (4580)

Event Date 01/25/2024

Event Type  Injury  

Manufacturer Narrative

Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.A review of the device history is not possible because the lot number was not communicated.Should additional information become available, it will be provided in a supplemental report.

Event Description

As reported: "in a loan of the t2 alpha, an important instrument was not in the set.This was not indicated by the kit room or planning at the shortage mail.This could be concluded by the representative on site when the operation was already in progress.As a result, the outcome was not optimal and the patient had to be operated on a second time in the same week.".

Manufacturer Narrative

The reported event could not be confirmed, since the device was not returned and no additional information was available.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.Indications of material, manufacturing, or design related problems were unable to be identified as the lot number was not communicated.Based on the available information the event was caused by a missing instrument in the loaner kit for which nc has been opened at the loan set department for investigation of this issue.If the device is returned or if any additional information is provided, the investigation will be reassessed.

Event Description

As reported: "in a loan of the t2 alpha, an important instrument was not in the set.This was not indicated by the kit room or planning at the shortage mail.This could be concluded by the representative on site when the operation was already in progress.As a result, the outcome was not optimal and the patient had to be operated on a second time in the same week.".

• Brand Name: SPREADING RECON LAG SCREWDRIVER BIT IMN INSTRUMENTS
• Type of Device: SCREWDRIVER
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 18739522
• MDR Text Key: 335761596
• Report Number: 0009610622-2024-00078
• Device Sequence Number: 1
• Product Code: HXX
• Combination Product (y/n): N
• Reporter Country Code: BE
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 23510220
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/25/2024
• Initial Date FDA Received: 02/20/2024
• 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): Required Intervention