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

Model Number	21132-4
Health Effect - Clinical Code	Limb Fracture (4518)
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: HUMERAL HEAD PLATE, SMALL, 4-HOLE
• Manufacturer (Section D): I.T.S. GMBH; autal 28; lassnitzh[?]he, styria 8301 ; AU 8301
• MDR Report Key: 11336435
• Report Number: 3004369035-2021-00001
• Device Sequence Number: 3382032
• Product Code: HRS
• UDI-Device Identifier: 09120034305184
• UDI-Public: 09120034305184
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K051412
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/17/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: 21132-4
• Device Catalogue Number: 21132-4
• Device Lot Number: 43/0512
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/03/2021
• Initial Report FDA Received Date: 02/17/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR
• Patient Weight: 96