MAUDE Adverse Event Report: STRYKER GMBH UNKNOWN LOCKING SCREW; SCREW, FIXATION, BONE

Catalog Number UNK_SEL

Device Problems Difficult to Insert (1316); Device Difficult to Setup or Prepare (1487)

Patient Problem Insufficient Information (4580)

Event Date 01/04/2022

Event Type  malfunction  

Manufacturer Narrative

The device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Device disposition is unknown.

Event Description

As reported: "locking failure was occurred at the distal locking hole of the plate.The plate was bent, but in a position unrelated to the screw hole, and the surgeon was aware that the screw was not swung more than 15 degrees.The angle was confirmed with a drill guide.Even if the lock starts to engage, if the surgeon kept turning it, the lock came off.Circular metal fragments were also generated.".

Manufacturer Narrative

Please refer to h6 device code.The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were 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.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.No indications of material, manufacturing or design related problems were found during the investigation.If the device is returned or if any additional information is provided, the investigation will be reassessed.

Event Description

As reported: "locking failure was occurred at the distal locking hole of the plate.The plate was bent, but in a position unrelated to the screw hole, and the surgeon was aware that the screw was not swung more than 15 degrees.The angle was confirmed with a drill guide.Even if the lock starts to engage, if the surgeon kept turning it, the lock came off.Circular metal fragments were also generated.".

• Brand Name: UNKNOWN LOCKING SCREW
• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 13460507
• MDR Text Key: 286775919
• Report Number: 0008031020-2022-00040
• Device Sequence Number: 1
• Product Code: HWC
• 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,Followup
• Report Date: 10/05/2023

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_SEL
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/07/2022
• Initial Date FDA Received: 02/04/2022
• Supplement Dates Manufacturer Received: 10/04/2023
• Supplement Dates FDA Received: 10/05/2023
• 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