MAUDE Adverse Event Report: I.T.S. GMBH PROXIMAL HUMERAL PLATE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 04/25/2022

Event Type  Injury  

Manufacturer Narrative

As no article and lot no.Were provided, the batch documentation of random chosen lots were taken of hospitals in vorarlberg and we have inspected the dhf and including material certificate and the devices were processed through the normal manufacturing and inspection operations with no non-conformances or rework noted.The article met all dimensional and visual criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.As soon we receive the affected product back, we will initiate further investigation.

Event Description

We have received the information that during a metal-ex of proximal humeral plate it was visible that the surrounded tissue was discolored dark grey.No further information available.

• Brand Name: PROXIMAL HUMERAL PLATE
• Type of Device: PROXIMAL HUMERAL PLATE
• Manufacturer (Section D): I.T.S. GMBH; autal 28; lassnitzh[?]he, styria 8301 ; AU 8301
• Manufacturer (Section G): I.T.S. GMBH; autal 28; lassnitzh[?]he, styria 8301 ; AU 8301
• Manufacturer Contact: florian grill ; autal 28; lassnitzhoehe, styria 8301 ; AU 8301
• MDR Report Key: 14345146
• MDR Text Key: 291344485
• Report Number: 3004369035-2022-00005
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Date Manufacturer Received: 04/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Patient Sequence Number: 1
• Patient Outcome(s): Other