MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 CORAIL BONE IMPACTOR; HIP INSTRUMENTS : IMPACTORS

Catalog Number	L93205
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Implant date, explant date: device is an instrument and is not implanted/explanted.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.Johnson and johnson (b)(4) reported mdr staff has indicated bone tamp impactor is worn and damaged.The handle was found to be cracked.Product is no longer functional and replacement is required.The instrument associated with this report was not returned.With no more information and no instrument returned to examine, a root cause cannot be determined for this instrument.Based on the investigation, the need for corrective action is not indicated.Complaints will be monitored under post market surveillance (b)(4).
Event or Problem Description
Mdr staff has indicated product l93606 (bone tamp impactor) was worn and damaged.The handle was found to be cracked.
Additional Manufacturer Narrative
Product complaint # (b)(4).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.Johnson and johnson canada reported mdr staff has indicated bone tamp impactor is worn and damaged.The handle was found to be cracked.Product is no longer functional and replacement is required.The instrument associated with this report was not returned.With no more information and no instrument returned to examine, a root cause cannot be determined for this instrument.Based on the investigation, the need for corrective action is not indicated.Complaints will be monitored under post market surveillance sep 419.Device history lot : null.Device history batch : null.Device history review : null.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.Device is an instrument and is not implanted/explanted.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.Johnson and johnson canada reported mdr staff has indicated bone tamp impactor is worn and damaged.The handle was found to be cracked.Product is no longer functional and replacement is required.The instrument associated with this report was not returned.With no more information and no instrument returned to examine, a root cause cannot be determined for this instrument.Based on the investigation, the need for corrective action is not indicated.Complaints will be monitored under post market surveillance sep 419.

• Brand Name: CORAIL BONE IMPACTOR
• Common Device Name: HIP INSTRUMENTS : IMPACTORS
• Manufacturer (Section D): DEPUY FRANCE SAS - 3003895575; 7 allee irene joliot-curie; b.p. 256; saint priest cedex 69801 ; FR 69801
• MDR Report Key: 8332566
• Report Number: 1818910-2019-84246
• Device Sequence Number: 154897
• Product Code: HWA
• UDI-Device Identifier: 10603295260707
• UDI-Public: 10603295260707
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: UNK
• 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
• Report Date (Section B): 01/25/2019

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: L93205
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/25/2019
• Supplement Date Received by Manufacturer: 02/16/2019
• Initial Report FDA Received Date: 02/12/2019
• Supplement Report FDA Received Date: 02/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1