MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 QUICKSET ACE GRATER HEAD 45MM; HIP INSTRUMENTS : REAMERS

Catalog Number 244000545

Device Problems Crack (1135); Dull, Blunt (2407); Failure to Cut (2587)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/01/2019

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

Acetabular reamer shells are dull.Customer reference/po/service --> to follow, was surgery delayed due to the reported event? --> no, was procedure successfully completed? --> no, were fragments generated? --> unknown, if yes, were they removed easily without additional intervention? --> unknown, patient status/ outcome / consequences --> no, was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required: --> unknown, is the patient part of a clinical study --> unknown, (b)(4), device property of -->other, device in possession of -->none, (b)(4), device property of -->other, device in possession of -->none, (b)(4), device property of -->other, device in possession of -->none, (b)(4), device property of -->other, device in possession of -->none, (b)(4), device property of -->other, device in possession of -->none, (b)(4), device property of -->other, device in possession of -->none, (b)(4), device property of -->other, device in possession of -->none, (b)(4), device property of -->none, device in possession of -->none, (b)(4), device property of -->none, device in possession of -->none, (b)(4), device property of -->none, device in possession of -->none, (b)(4), device property of -->none, device in possession of -->none, (b)(4), device property of -->none, device in possession of -->none, (b)(4), device property of -->none, device in possession of -->none, (b)(4), device property of -->none, device in possession of -->none, (b)(4), device property of -->none, device in possession of -->none, (b)(4), device property of -->none, device in possession of -->none, (b)(4), device property of -->none, device in possession of -->none, (b)(4), device property of -->none, device in possession of -->none by checking this box i certify that all information that are known/available has been disclosed.If any new information will be made available, the additional information will be submitted through cst.--> true.

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.The root cause could not be determined.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.

Manufacturer Narrative

Product complaint#: (b)(4).Investigation summary: examination of the returned instrument confirmed the reported observation and also found a small crack on reamer.The root cause is attributed to heavy usage/ wear out over time.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.Added: d4 (lot#), d10 (concomitant medical products), h4 (device manufacture date), h6.Corrected: h3 (device evaluated by mfr).Device history lot: null.Device history batch: null.Device history review: null.

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.H10 additional narrative: product complaint # (b)(4).Investigation summary: examination of the returned instrument confirmed the reported observation and also found a small crack on reamer.The root cause is attributed to heavy usage/ wear out over time.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.

• Brand Name: QUICKSET ACE GRATER HEAD 45MM
• Type of Device: HIP INSTRUMENTS : REAMERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 8612632
• MDR Text Key: 145251157
• Report Number: 1818910-2019-93561
• Device Sequence Number: 1
• Product Code: HTO
• UDI-Device Identifier: 10603295123927
• UDI-Public: 10603295123927
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 244000545
• Device Lot Number: A0111
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2019
• Date Manufacturer Received: 04/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1