MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 QUICKSET ACE GRATER HEAD 39MM; HIP INSTRUMENTS : REAMERS

Catalog Number 244000539

Device Problem Material Discolored (1170)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/06/2018

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

Event: after the process of pre-washing and sterilized the product (drill) were oxidized.Details of the event: the new products entered yesterday ((b)(6) 2018) to the los arcos sanatorium, which were washed and brushed by hand one by one inside and outside, with 10 minutes of submerged.This process was done 3 times yesterday.Today they were steam sterilized and when they came out they had spots of drops.They were submerged again with enzymatic for 10 minutes and when went back, they were brushed one by one and with a sponge and all the spots were removed.After this, they was put in the process of washing and drying machine and finished this cycle , it was identified that those have the small laser letter were oxidized.I detail below the list of code and lot of them, are 25 in total: product information: code: d244000539, lot: so2025029, lot: so2025029; d244000540, so2025253, so2022304; d244000541, so2024835, so2024835; d244000542, so2015969, so2021809; d244000545, so2025326, so2025326; d244000548, so2026361, so2020326; d244000549, so2019713, so2019713; d244000552, so2017907, so2010097; d244000553, so2020408, so2025079; d244000554, so2025706, so2025709; d244000557, so2025594, d244000560, so2025699, d244000566, so2025009, so2025009.As the product complaint has several products (ip), we registered 2 complaints (b)(4).The complaint (b)(4) involved: d244000552, so2017907, so2010097; d244000553, so2020408, so2025079; d244000554, so2025706, so2025709; d244000557, so2025594; d244000560, so2025699; d244000566, so2025009, so2025009.

Manufacturer Narrative

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.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 39MM
• Type of Device: HIP INSTRUMENTS : REAMERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• 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: 7645138
• MDR Text Key: 113013421
• Report Number: 1818910-2018-63379
• Device Sequence Number: 1
• Product Code: HTO
• UDI-Device Identifier: 10603295123866
• UDI-Public: 10603295123866
• Combination Product (y/n): N
• Reporter Country Code: AR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 244000539
• Device Lot Number: SO2025029
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/06/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/13/2016
• 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