MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE NOTCH GUIDE SZ 6; ATTUNE INSTRUMENTS : RESECTION BLOCKS/DEVICES

Model Number 2545-00-026

Device Problems Naturally Worn (2988); Illegible Information (4050)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/04/2022

Event Type  malfunction  

Event Description

It was reported that the painted numbers on attune instruments shedding white paint from numbered cutting block during preparation in sterilizing department for use.Concerns the debris could end up in a patient's wound as a foreign body.Attune ps notch cutting guides.Product no and lot numbers unidentified on product search.Every effort made to locate product on the search function.

Manufacturer Narrative

Product complaint # (b)(4).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: no device associated with this report was received for examination.All available evidence were reviewed.Based on the information provided it was identified that the mold size marking is worn.Also, can be observed that device has scratches on the notch guide, therefore, the allegation can be confirmed.No other issues were observed.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.Device history lot: the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

Manufacturer Narrative

Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, 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 report, a follow-up report will be filed as appropriate.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.All available evidence were reviewed.Based on the information provided it was identified that the mold size marking is worn.Also, can be observed that device has scratches on the notch guide, therefore, the allegation can be confirmed.No other issues were observed.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.Device history lot : the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

Manufacturer Narrative

Product complaint # : (b)(4).Investigation summary : the device associated with this report was returned for analysis.Review of the photographic evidence and visual analysis revealed that the mold white markings have worn and are difficult to read.Also the device has scratches on the notch guide, therefore, the allegation can be confirmed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot : the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

• Brand Name: ATTUNE NOTCH GUIDE SZ 6
• Type of Device: ATTUNE INSTRUMENTS : RESECTION BLOCKS/DEVICES
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 14414253
• MDR Text Key: 291808953
• Report Number: 1818910-2022-08978
• Device Sequence Number: 1
• Product Code: HTZ
• UDI-Device Identifier: 10603295130437
• UDI-Public: 10603295130437
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 05/16/2022

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
• Device Operator: Health Professional
• Device Model Number: 2545-00-026
• Device Catalogue Number: 254500026
• Device Lot Number: PG259813
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/04/2022
• Initial Date FDA Received: 05/16/2022
• Supplement Dates Manufacturer Received: 08/01/2022; 10/24/2022; 12/27/2022; 01/13/2023
• Supplement Dates FDA Received: 08/02/2022; 10/25/2022; 12/27/2022; 01/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/29/2016
• 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