MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ADV+ CUTTING GUIDE RT; EXTREMITY INSTRUMENTS : RESECTION BLOCKS/DEVICES

Model Number	2128-62-110
Medical Device Problem Codes	Device-Device Incompatibility (2919); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/16/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint #(b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on 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.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 pin jammed in the guide.
Additional Manufacturer Narrative
(b)(4).Investigation summary = > per the event description, this complaint (pc-001357362) is capturing the delivery service issue for the cutting guide being shipped back to the customer after the customer had previous reported a product issue with the device.The device was previously reported on (b)(6) for the same product issue observed again later by the customer in (b)(6) the investigation of the product malfunction is captured under (b)(6) the delivery service issue was escalated as a quality issue (qi) by the loaner site.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 records evaluation (mre) was not performed.
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 : per the event description, this complaint ((b)(4)) is capturing the delivery service issue for the cutting guide being shipped back to the customer after the customer had previous reported a product issue with the device.The device was previously reported on (b)(4) for the same product issue observed again later by the customer in (b)(4)).The investigation of the product malfunction is captured under (b)(4).The delivery service issue was escalated as a quality issue (qi) by the loaner site.
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.H10 additional narrative:  if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
Additional information received indicated that there was no surgical delay.The procedure completed.One pin was used instead of two and the cut was completed.

• Brand Name: ADV+ CUTTING GUIDE RT
• Common Device Name: EXTREMITY INSTRUMENTS : RESECTION BLOCKS/DEVICES
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 16994489
• Report Number: 1818910-2023-10881
• Device Sequence Number: 15220586
• Product Code: HTZ
• UDI-Device Identifier: 10603295089810
• UDI-Public: 10603295089810
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 05/24/2023

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: 2128-62-110
• Device Catalogue Number: 212862110
• Device Lot Number: NW149979
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/18/2023
• Supplement Date Received by Manufacturer: 05/23/2023; 06/06/2023; 07/28/2023; 08/11/2023; 08/11/2023
• Initial Report FDA Received Date: 05/24/2023
• Supplement Report FDA Received Date: 05/31/2023; 06/13/2023; 07/31/2023; 08/14/2023; 08/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/11/2013
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown