MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SUMMIT ANGLED INSERTER; HIP INSTRUMENTS : IMPACTORS

Model Number	2570-05-125
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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
It was reported that both of these products were found broken.No surgical delay.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device was received for examination, therefore the reported event could not be confirmed.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.No device was received for examination, therefore the reported event could not be confirmed.In order to determine if a lot related issue was possible, a worldwide complaint database search was performed.A worldwide complaint database search found one additional related report (b)(4) against the provided product code, lot number combination.When investigated, the additional report found the inserter likely failed due to cyclic bending loading, due to repeated slightly off-axis impactions, resulting in high stress low cycle fatigue crack initiation and propagation to failure.The investigation could not draw any conclusions about the current reported event without the device to examine.Based on the inability to determine a root cause, a need for corrective action is not indicated.Monitor complaints through sep-419.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.

• Brand Name: SUMMIT ANGLED INSERTER
• Common Device Name: HIP INSTRUMENTS : IMPACTORS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9843618
• Report Number: 1818910-2020-08324
• Device Sequence Number: 16328782
• Product Code: HWR
• UDI-Device Identifier: 10603295143222
• UDI-Public: 10603295143222
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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,Followup
• Report Date (Section B): 03/02/2020

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: 2570-05-125
• Device Catalogue Number: 257005125
• Device Lot Number: CV168812
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/02/2020
• Supplement Date Received by Manufacturer: 04/15/2020
• Initial Report FDA Received Date: 03/17/2020
• Supplement Report FDA Received Date: 04/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1