MAUDE Adverse Event Report: I.T.S. GMBH CLAVICLE PLATE, 2.5MM, 8-HOLE

Model Number	21121-8
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Information (3190)
Date of Event	06/13/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
We have inspected the qc documents of the affected product 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.The additional information from our distributor received from the surgeon states, that the patient lifted weights 3,5 weeks after surgery.The intensive weight bearing does not comply with the post-operative instructions.
Event or Problem Description
It was reported that a clavicle plate 2.5mm, 8-hole broke postoperatively.Original implant date (b)(6) 2019.

• Brand Name: CLAVICLE PLATE, 2.5MM, 8-HOLE
• Common Device Name: CLAVICLE PLATE, 2.5MM, 8-HOLE
• Manufacturer (Section D): I.T.S. GMBH; autal 28; lassnitzh?he, 8301 ; AU 8301
• MDR Report Key: 8783902
• Report Number: 3004369035-2019-00010
• Device Sequence Number: 13870236
• Product Code: HRS
• UDI-Device Identifier: 09120034304415
• UDI-Public: 09120034304415
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K050852
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/12/2019

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: 21121-8
• Device Catalogue Number: 21121-8
• Device Lot Number: 00/0717-01
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/11/2019
• Initial Report FDA Received Date: 07/12/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 26 YR