MAUDE Adverse Event Report: I.T.S. GMBH HUMERAL HEAD PLATE, SMALL, 4-HOLE

Model Number 21132-4

Device Problem Fracture (1260)

Patient Problem Limb Fracture (4518)

Event Type  Injury  

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.As soon further information from the distributor gets available a follow-up report will be submitted.

Event Description

It was reported that a proximal humeral plate broke 2 months post-op.Original implant date (b)(6) 2020.

• Brand Name: HUMERAL HEAD PLATE, SMALL, 4-HOLE
• Type of Device: HUMERAL HEAD PLATE, SMALL, 4-HOLE
• 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: 11336435
• MDR Text Key: 232159492
• Report Number: 3004369035-2021-00001
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 09120034305184
• UDI-Public: 09120034305184
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K051412
• 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: 02/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 21132-4
• Device Catalogue Number: 21132-4
• Device Lot Number: 43/0512
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/03/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR
• Patient Weight: 96