MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US G C.A.P. HUM HD SHAPER 52X18; EXTREMITY INSTRUMENTS : REAMERS

Catalog Number	223081070
Medical Device Problem Codes	Break (1069); Material Deformation (2976); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/12/2019
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
It was reported that the shapers were broken due to usage.They were worn.
Additional Manufacturer Narrative
Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: added: d10, h6.Investigation summary: examination of the returned device confirmed the reported event.The investigation findings did not indicate that a broader investigation or corrective action was necessary.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.The customer reported the shapers were broken due to usage.The complaint sample consists of (1) (b)(4) g c.A.P.Hum hd shaper 52x18, lot code a0804.The lot code indicates a vendor manufacture date of august of 2004.Examination of the returned g c.A.P.Hum hd shaper confirmed breakage between the cup component and step reamer component.All pieces of the device were returned.There is wear on the cutting teeth consistent with repetitive contact with patient bone.A previous investigation found product development implemented eco# (b)(4) on (b)(6) 2009 so the assembly of the reamer will now have a weld between the cup and the step reamer to not allow any movement between the two components.The sample was manufactured prior to the change.No further action indicated.The etched lot code indicated date of manufacture in june 2006.The root cause is attributed to device design.The returned device was manufactured prior to the implementation of eco# (b)(4) on march 30, 2009 and no broader investigation or corrective action was necessary.Complaint trends will be monitored by post market surveillance through sep-419.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.Device history lot: null.Device history batch:null.Device history review: null.

• Brand Name: G C.A.P. HUM HD SHAPER 52X18
• Common Device Name: EXTREMITY INSTRUMENTS : REAMERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9152048
• Report Number: 1818910-2019-107544
• Device Sequence Number: 14126739
• Product Code: HTO
• UDI-Device Identifier: 10603295105060
• UDI-Public: 10603295105060
• Combination Product (Y/N): N
• 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): 09/12/2019

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 Catalogue Number: 223081070
• Device Lot Number: A0804
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2019
• Initial Date Received by Manufacturer: 09/12/2019
• Supplement Date Received by Manufacturer: 10/29/2019
• Initial Report FDA Received Date: 10/03/2019
• Supplement Report FDA Received Date: 11/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1