MAUDE Adverse Event Report: DEPUY FRANCE SAS 3003895575 GLEN RESURFACING REAMER D27 MM; EXTREMITY INSTRUMENTS : REAMERS

Catalog Number 230788027

Device Problems Dull, Blunt (2407); Naturally Worn (2988)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/20/2018

Event Type  malfunction  

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 Description

Instrument is worn and needs to be replaced.Nothing fell into patient.No patient consequence and no surgical delay.One impacted, one needing replacement no charge replacement po# (b)(4).Sold to (b)(4); ship to (b)(4).Patient consequence? :no is the information being submitted for this complaint all the details that are known/available regarding this event? : yes.

Manufacturer Narrative

Product complaint # pc-(b)(4).Investigation summary the device associated with this report was not returned for examination.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: GLEN RESURFACING REAMER D27 MM
• Type of Device: EXTREMITY INSTRUMENTS : REAMERS
• Manufacturer (Section D): DEPUY FRANCE SAS 3003895575; 7 allée irène joliot curie; bp 256; saint priest cedex 69801 ; FR 69801
• Manufacturer (Section G): DEPUY ORTHOPAEDICS INC 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46582-0988 ; 5743725905
• MDR Report Key: 7682587
• MDR Text Key: 113876684
• Report Number: 1818910-2018-64315
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 10603295116479
• UDI-Public: 10603295116479
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K170748
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 230788027
• Device Lot Number: 5112870
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/10/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/14/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization