MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US GLO ADV ANTIROTATION PEG GRAS; EXTREMITY INSTRUMENTS : ALIGNMENT DEVICES

Model Number	2128-61-011
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/25/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint: (b)(4).Investigation summary: examination of the returned device confirmed the reported breakage.Examination of the returned instrument confirmed one of the two grasp features has broken off.The broken off fragment was not returned.The initial reporting stated no pieces of the device were left in the patient.The fracture surface is consistent with a low stress high cycle fatigue.The other tip exhibits deformation, also consistent with fatigue.The instrument was used beyond its intended life.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.
Event or Problem Description
It was reported that one of the ends of the global adv anti-rotation peg grasper broke off during removing one of the pegs.The piece was found, and disposed of.No surgical delay.

• Brand Name: GLO ADV ANTIROTATION PEG GRAS
• Common Device Name: EXTREMITY INSTRUMENTS : ALIGNMENT DEVICES
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10666755
• Report Number: 1818910-2020-22049
• Device Sequence Number: 17033587
• Product Code: HWA
• UDI-Device Identifier: 10603295089339
• UDI-Public: 10603295089339
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 2128-61-011
• Device Catalogue Number: 212861011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/25/2020
• Initial Report FDA Received Date: 10/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1