MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATUN TIB AUG UNIV SZ 7/8 5MM; KNEE TIBIAL TRAY ACCESSORY

Model Number	1523-07-001
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/10/2021
Type of Reportable Event	Malfunction
Additional 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.
Event or Problem Description
It was reported that incorrect screws for the 5mm tibial augment were placed in the packaging of 2 size 7/8 5mm implants.Both of these augment packages shared the same lot number (j6304z).The screws in the set were for a 10mm augment.They were clearly too long.In order to resolve the issue, screws inside of the size 5/6 5mm tibial augments were opened.Both 7/8 packages had the wrong screws in them.There was a surgical delay of 5 minutes.
Additional Manufacturer Narrative
Product complaint # : (b)(4).Investigation summary : no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot : dhr review: review of material number 152307001, lot j6304z revealed no previous nc¿s.Review of the mes audit trail for lot j6304z did not reveal any deviations to the process.Screw material number 152300001, lot number j6001m has no previous ncs.Nc¿s.See attachments for details.
Additional 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.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: examination of the returned device confirmed, the reported event.Depuy considers, the investigation closed.Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary.Device history lot: dhr review: review of material number 152307001, lot#: j6304z revealed, no previous nc¿s.Review of the mes audit trail for lot#: j6304z did not reveal, any deviations to the process.Screw material number 152300001, lot number#: j6001m has no previous ncs.
Additional Manufacturer Narrative
H7 and h9: recall information provided.

• Brand Name: ATUN TIB AUG UNIV SZ 7/8 5MM
• Common Device Name: KNEE TIBIAL TRAY ACCESSORY
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY RAYNHAM, A DIV. OF DEPUY ORTHO 1219655; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 12087797
• Report Number: 1818910-2021-13793
• Device Sequence Number: 3869992
• Product Code: JWH
• UDI-Device Identifier: 10603295057642
• UDI-Public: 10603295057642
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 06/10/2021

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 Model Number: 1523-07-001
• Device Catalogue Number: 152307001
• Device Lot Number: J6304Z
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 06/10/2021
• Supplement Date Received by Manufacturer: 08/09/2021; 09/13/2021; 11/02/2021; 02/28/2024
• Initial Report FDA Received Date: 06/29/2021
• Supplement Report FDA Received Date: 08/09/2021; 09/13/2021; 11/03/2021; 03/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/27/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 1818910-09/07/2021-006-R
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ATUN TIB AUG UNIV SZ 7/8 5MM.; ATUN TIB AUG UNIV SZ 7/8 5MM.
• Patient Age: 64 YR
• Patient Sex: Unknown