MAUDE Adverse Event Report: I.T.S. GMBH DISTAL FEMUR PLATE, 9-HOLE, RIGHT

Model Number 21301-9

Device Problems Fracture (1260); Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 04/02/2022

Event Type  Injury  

Event Description

It was reported that a distal femur plate 9-hole broke approx.3 months post-op.Device used for diagnosis not known.

Manufacturer Narrative

We have inspected the qc documents of the lot and the quality inspection forms as well as the material certificates showed no deviations and complies with the specifications.The quality forms met all dimensional and visual criteria at the time of release with no issues documented during the manufacturing that would contribute to this complaint condition.A review of the raw material device history record revealed no deviation.The material was determined to be conforming and was used as is per product development approval.If further information gets available, as supplemental report will be filed.

• Brand Name: DISTAL FEMUR PLATE, 9-HOLE, RIGHT
• Type of Device: DISTAL FEMUR PLATE, 9-HOLE, RIGHT
• 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; lassnitzh[?]he, styria 8301 ; AU 8301
• MDR Report Key: 14427034
• MDR Text Key: 291946702
• Report Number: 3004369035-2022-00007
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 09120034307058
• UDI-Public: 09120034307058
• Combination Product (y/n): Y
• Reporter Country Code: SF
• PMA/PMN Number: K093868
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 21301-9
• Device Catalogue Number: 21301-9
• Device Lot Number: 26/F549492
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2022
• Date Manufacturer Received: 05/03/2022
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR
• Patient Weight: 85 KG