MAUDE Adverse Event Report: STRYKER GMBH UNKNOWN PROXIMAL SCREW; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number UNK_KIE

Device Problem Malposition of Device (2616)

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

Event Date 11/21/2023

Event Type  malfunction  

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: "the proximal screw deviated from the screw hole of the nail.The surgeon is considering revision surgery and have not yet made a decision.".

Manufacturer Narrative

The reported event could not be confirmed since the device was not returned for evaluation and no other evidence was provided.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 was not possible because the catalog number and lot number were not communicated.Generally, it is pointed out that a pre-functional check has to be performed before use.Doing so, any potential misalignment will be detected prior to treatment.Indications of material, manufacturing, or design related problems were unable to be identified as the catalog number and lot number were not communicated.The screw in question was the only one filed as misplaced.No event was reported regarding placing for the remaining screws.We received the information that, from medical point of view, ¿nothing is being done.Revision surgery is not planned.¿ leaving the patient in given condition is in the responsibility of the surgeon.If the device is returned or if any additional information is provided, the investigation will be reassessed.Based on investigation, the root cause was attributed to a user related issue.With available information a product deficiency was not verified.

Event Description

As reported: "the proximal screw deviated from the screw hole of the nail.The surgeon is considering revision surgery and have not yet made a decision.".

• Brand Name: UNKNOWN PROXIMAL SCREW
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• 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: 18319636
• MDR Text Key: 330393339
• Report Number: 0009610622-2023-00449
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 12/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2023
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1