MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 DELTA CTA HEAD REAMER; EXTREMITY INSTRUMENTS : REAMERS

Catalog Number	230782003
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: examination of the returned device confirmed the reported event.The root cause was determined to be wear out from normal use.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.
Event or Problem Description
It was reported that the liner trial was cracked and won¿t trial the head correctly due to cracked.The cta guide and the reamer have burrs internally where they meet together and they bind up when put together.Tolerances are not correct.No surgical delay.

• Brand Name: DELTA CTA HEAD REAMER
• Common Device Name: EXTREMITY INSTRUMENTS : REAMERS
• Manufacturer (Section D): DEPUY FRANCE SAS - 3003895575; 7 allee irene joliot-curie; b.p. 256; saint priest cedex 69801 ; FR 69801
• MDR Report Key: 9171980
• Report Number: 1818910-2019-108710
• Device Sequence Number: 2537454
• Product Code: LXH
• UDI-Device Identifier: 10603295116356
• UDI-Public: 10603295116356
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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
• Report Date (Section B): 08/19/2019

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: 230782003
• Device Lot Number: 5243274
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/18/2019
• Initial Report FDA Received Date: 10/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1