MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ACTIS STD NK SZ6/7; FEMORAL STEM TRIALS

Catalog Number	201002400
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2019
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
Neck segment is loose on broach.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the 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.Product complaint #: (b)(4).Investigation summary: the instrument associated with this report was not returned.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.Device history lot: null.Device history batch: null.Device history review: null.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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.Added: d10, h6.Investigation summary : examination of the returned instrument found this instrument to be of the old design.The root cause is attributed to design.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.The instrument associated with this report was not returned.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.It was reported neck segment is loose on broach.The instrument associated with this report was not returned.A design change was implemented on (b)(6) 2017 via co (b)(4).The hole diameter and tolerance along with the pin diameter were changed for a more constrained fit to the broach.The lot number required to determine manufacturing age was not known.With no instrument returned and no more information, no root cause can be determined for this specific instrument.No further action required.Complaints will be monitored under post market surveillance (b)(4).Update: (b)(4) 2019.It was reported neck segment is loose on broach.Examination found this instrument to be of the old design.Depuy product development states due to tolerances, there is a possibility of a loose fit.A design change was implemented on (b)(6) 2017 via co (b)(4).The hole diameter and tolerance along with the pin diameter were changed for a more constrained fit to the broach.The returned instrument was manufactured before design change.Based on the investigation for this specific instrument, the need for corrective action is not indicated.Complaints will be monitored under post market surveillance (b)(4).Device history lot : null.Device history batch : null.Device history review : null.

• Brand Name: ACTIS STD NK SZ6/7
• Common Device Name: FEMORAL STEM TRIALS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 8629115
• Report Number: 1818910-2019-94202
• Device Sequence Number: 19384969
• Product Code: KWL
• UDI-Device Identifier: 10603295393801
• UDI-Public: 10603295393801
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K150862
• 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,Followup,Followup
• Report Date (Section B): 05/06/2019

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: 201002400
• Device Lot Number: PG266931
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2019
• Initial Date Received by Manufacturer: 05/06/2019
• Supplement Date Received by Manufacturer: 06/26/2019; 08/02/2019; 10/14/2019
• Initial Report FDA Received Date: 05/21/2019
• Supplement Report FDA Received Date: 06/27/2019; 08/16/2019; 11/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1