MAUDE Adverse Event Report: I.T.S. GMBH CANCELLOUS SCREW, LOCKING SH, D=3.5MM, L=38MM

Model Number	37352-38-N
Medical Device Problem Code	Inaccurate Information (4051)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
During the quality inspection of a returned loaner set from austria, we have detected, that a class ii titanium implant bone screw has the wrong article number and lot number laser marked on it.The label states that it is the article number 37352-38-n with lot no.679/022244, which complies with the article itself, but the laser marking shows the article number 37352-36-n with lot no.679/022241.The discrepancy in laser marking of this bone screw could be limited to one single batch.
Additional Manufacturer Narrative
During the quality inspection of a returned loaner set from austria, we have detected, that a class ii titanium implant bone screw has the wrong article number and lot number laser marked on it.The label states that it is the article number 37352-38-n with lot no.679/022244, which complies with the article itself, but the laser marking shows the article number 37352-36-n with lot no.679/022241.The discrepancy in laser marking of this bone screw could be limited to one single batch.The label indicates the correct article number 37352-38-n and lot number 679/022244 and the actual product complies with these information.So, when re-filling the article in the screw module of the tray, the length gets verified on the appropriate scale and inserted in the correct spot for a 38mm screw.During surgery the or staff and surgeons select the implant according to the length, which gets verified again prior implantation on the scale.

• Brand Name: CANCELLOUS SCREW, LOCKING SH, D=3.5MM, L=38MM
• Common Device Name: CANCELLOUS SCREW, LOCKING SH, D=3.5MM, L=38MM
• Manufacturer (Section D): I.T.S. GMBH; autal 28; lassnitzhoehe, styria 8301 ; AU 8301
• Manufacturer (Section G): I.T.S. GMBH; autal 28; lassnitzhoehe, styria 8301 ; AU 8301
• Manufacturer Contact: florian grill ; autal 28; lassnitzhoehe, styria 8301 ; AU 8301
• MDR Report Key: 19760912
• Report Number: 3004369035-2024-00724
• Device Sequence Number: 12956412
• Product Code: HWC
• UDI-Device Identifier: 09120047295373
• UDI-Public: 09120047295373
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K051642
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall,Notification
• Type of Report: Initial
• Report Date (Section B): 07/17/2024

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 Model Number: 37352-38-N
• Device Lot Number: 679/022244
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/03/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/03/2024
• Initial Report FDA Received Date: 07/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2022
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown