MAUDE Adverse Event Report: STRYKER GMBH UNKNOWN M6 NUTS; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Catalog Number UNK_SEL

Device Problems Misassembled (1398); Unintended System Motion (1430); Unintended Movement (3026)

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

Event Date 05/11/2022

Event Type  malfunction  

Event Description

The sales representative has reported "i have recently had 2 cases of hlrf at (b)(6) hospital which both went well and the surgeon was happy with the cases.However i saw him yesterday at a conference and he mentioned that when the patient came back for a review, the m6 nuts that are on the threaded rods had loosened.I asked if there was a chance that the patient had loosened which he said he didn't think it would be possible and also asked if it was it just 1 nut that had loosened but he said it was on most of them." no revision required for the patient as the nuts were just tightened up when the patient was reviewed.

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.Device disposition unknown.

Manufacturer Narrative

Please note the corrections to h6 device code.

Event Description

The sales representative has reported "i have recently had 2 cases of hlrf at royal berks hospital which both went well and the surgeon was happy with the cases.However i saw him yesterday at a conference and he mentioned that when the patient came back for a review, the m6 nuts that are on the threaded rods had loosened.I asked if there was a chance that the patient had loosened which he said he didn't think it would be possible and also asked if it was it just 1 nut that had loosened but he said it was on most of them." no revision required for the patient as the nuts were just tightened up when the patient was reviewed.

• Brand Name: UNKNOWN M6 NUTS
• Type of Device: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
• 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: 14599649
• MDR Text Key: 294023437
• Report Number: 0008031020-2022-00273
• Device Sequence Number: 1
• Product Code: KTT
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNK_SEL
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/25/2023
• 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