MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG MMF SCREWS, 2.0X12MM, CROSS-PIN, SELF DRILLING, 1/P, STERILE; IMPLANT

Catalog Number	21-20362
Medical Device Problem Codes	Loosening of Implant Not Related to Bone-Ingrowth (4002); Migration (4003)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	08/03/2023
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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.
Additional Manufacturer Narrative
Corrected: further evaluation of initial information revealed, that four patients were affected and it is therefore required to address this in separate complaints.This reported case is now documented / covered under (b)(4), complaint (b)(4) and the reported 0008010177-2023-00060 covers the complaint record.
Event or Problem 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.

• Brand Name: MMF SCREWS, 2.0X12MM, CROSS-PIN, SELF DRILLING, 1/P, STERILE
• Common Device Name: 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: 17740759
• Report Number: 0008010177-2023-00060
• Device Sequence Number: 5838797
• Product Code: DZL
• UDI-Device Identifier: 07613154716302
• UDI-Public: 07613154716302
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K050535
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/01/2023

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
• Operator of Device: Health Professional
• Device Catalogue Number: 21-20362
• Device Lot Number: 1000518701
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/03/2023
• Supplement Date Received by Manufacturer: 08/03/2023
• Initial Report FDA Received Date: 09/13/2023
• Supplement Report FDA Received Date: 12/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown