MAUDE Adverse Event Report: I.T.S. GMBH CLAVICLE PLATE MEDIAL

Model Number	21122-8
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Information (3190)
Date of Event	10/27/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
We received the complaint of a broken clavicle plate medial 8-hole.The article and the lot number were provided, so we have inspected the quality inspection forms and material certificates and no deviation was detected.Furthermore, we have consulted an experienced trauma surgeon to gain his clinical statement, summarized as follows: a short oblique fracture with a long bone wedge and small fragments.The plate position is well chosen, but two screws medial to the fracture are still in the fracture region.Thus, considering the ao principles, only 4 cortices remain at the medial side for stabilizing the plate.As stated in the technique guide, no rigid fixation should be achieved close to fracture (locking screws) and visible on the x-ray two locking screws were used to fracture at the lateral side.
Event or Problem Description
Broken clavicle plate medial 8-hole.

• Brand Name: CLAVICLE PLATE MEDIAL
• Common Device Name: CLAVICLE PLATE MEDIAL
• Manufacturer (Section D): I.T.S. GMBH; autal 28; lassnitzh?he, styria 8301 ; AU 8301
• MDR Report Key: 6696333
• Report Number: 3004369035-2017-00009
• Device Sequence Number: 11012785
• Product Code: HRS
• UDI-Device Identifier: 09120034305207
• UDI-Public: 09120034305207
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/06/2017

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: 21122-8
• Device Catalogue Number: 21122-8
• Device Lot Number: 679/071611
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/14/2016
• Initial Report FDA Received Date: 07/10/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 52 YR
• Patient Weight: 176