MAUDE Adverse Event Report: I.T.S. GMBH DISTAL ULNA PLATE, 6-HOLE

Model Number	21233-6
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Information (3190)
Date of Event	10/23/2013
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As no and lot-no.Was provided, the device history record (dhr) of the last three shipments of a 6-hole distal ulna plate (21233-6) that were shipped to i.T.S.Usa, were inspected and showed no deviations.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 complaint form states, that the patient lifted a baby, which doesn't comply with the post-operative instructions.
Event or Problem Description
It was reported that a distal ulna plate, 6-hole was determined to be broken postoperatively.Original implant date (b)(6) 2013.A revision surgery was performed on (b)(6) 2013.

• Brand Name: DISTAL ULNA PLATE, 6-HOLE
• Common Device Name: DISTAL ULNA PLATE, 6-HOLE
• Manufacturer (Section D): I.T.S. GMBH; autal 28; lassnitzh[?]he, styria 8301 ; AU 8301
• MDR Report Key: 8225458
• Report Number: 3004369035-2013-00005
• Device Sequence Number: 19289560
• Product Code: HRS
• UDI-Device Identifier: 09120047296530
• UDI-Public: 09120047296530
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K130008
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/08/2019

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: 21233-6
• Device Catalogue Number: 21233-6
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/18/2013
• Initial Report FDA Received Date: 01/08/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 52 YR