MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US HP MBT CEM PUNCH SZ 4-7; KNEE INSTRUMENT : TIBIAL KEEL PUNCH/BULLET

Model Number	9505-02-018
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/08/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint #: (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
The instrument´s both "noses" of the locking mechanism broke off.One metal fragment was found remaining in patient, the whereabouts of the second fragment is unknown.Patient underwent primary knee-tep left side on (b)(6) 2020, it is unknown whether both fragments broke off on this date/during this surgery.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: examination of the returned device confirmed the reported event.The device was manufactured on 15-sept-2011.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.H10 additional narrative: added: d10.Corrected: h3.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : examination of the returned device confirmed the reported event.The root cause is attributed to device design.A design change was implemented in 2014 to address the issue.The device was manufactured on 15-sept-2011.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.

• Brand Name: HP MBT CEM PUNCH SZ 4-7
• Common Device Name: KNEE INSTRUMENT : TIBIAL KEEL PUNCH/BULLET
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10321179
• Report Number: 1818910-2020-16796
• Device Sequence Number: 11558039
• Product Code: LRY
• UDI-Device Identifier: 10603295227380
• UDI-Public: 10603295227380
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/10/2020

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: 9505-02-018
• Device Catalogue Number: 950502018
• Device Lot Number: B0911
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2020
• Initial Date Received by Manufacturer: 07/10/2020
• Supplement Date Received by Manufacturer: 07/24/2020; 09/22/2020
• Initial Report FDA Received Date: 07/24/2020
• Supplement Report FDA Received Date: 07/31/2020; 09/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1