MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG MMF SCREWS, 2.0X8MM, CROSS-PIN, SELF DRILLING, 1/P, STERILE; IMPLANT

Catalog Number 21-20358

Device Problems Loosening of Implant Not Related to Bone-Ingrowth (4002); Migration (4003)

Patient Problem Discomfort (2330)

Event Date 08/03/2023

Event Type  malfunction  

Event Description

It was reported that the customer found the mmf screws were loose as if they ere not holding in place.It is not known at this time if there will be or has been a revision surgery to fix the loose screws.No other information is known at this time.

Manufacturer Narrative

The device has not yet been received at the manufacturer for testing.An evaluation will be conducted upon receipt of the device, and a follow-up report will be submitted after the quality investigation is complete.

Event Description

It was reported that the customer found the mmf screws were loose as if they are not holding in place.It is not known at this time if there will be or has been a revision surgery to fix the loose screws.No other information is known at this time.

Manufacturer Narrative

Based on the investigation steps performed no product problem indicating a non-conformity or unanticipated hazard/harm was identified.Therefore, no corrective action is required at this time.Should further information be available, the investigation will be re-evaluated.

• Brand Name: MMF SCREWS, 2.0X8MM, CROSS-PIN, SELF DRILLING, 1/P, STERILE
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11; GM D-79111
• Manufacturer (Section G): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11; GM D-79111
• Manufacturer Contact: rylee koole ; boetzingerstr. 41; freiburg D-791-11 ; GM D-79111 ; 7614888208
• MDR Report Key: 17740852
• MDR Text Key: 323332335
• Report Number: 0008010177-2023-00061
• Device Sequence Number: 1
• Product Code: DZL
• UDI-Device Identifier: 07613154716289
• UDI-Public: 07613154716289
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K050535
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/27/2023

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: 21-20358
• Device Lot Number: 1000480137 OR 1000518701
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/03/2023
• Initial Date FDA Received: 09/13/2023
• Supplement Dates Manufacturer Received: 08/03/2023
• Supplement Dates FDA Received: 11/27/2023
• 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
• Patient Outcome(s): Other