MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 CAS LIGAMENT TENSOR SIZE 2-XF; KNEE INSTRUMENT: TENSIONING DEVICE

Catalog Number	129901080
Medical Device Problem Codes	Material Deformation (2976); Naturally Worn (2988); Scratched Material (3020)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).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, or its employees that the report constitutes an admission that the product, 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 report, a follow-up report will be filed as appropriate.
Event or Problem Description
It was reported that the sensors have become roughened and sharp and need replacing.
Event or Problem Description
Additional information was received and states that: 1.What was the exact allegation against the device? was it worn, cracked, broken into pieces, bent, stripped, cross threaded or any device interaction? the allegation was the sensor tensors were quite warn and could be a risk of the coating coming off during surgery, as well the surface needs to be smooth as to attain an accurate graph so having the surface all scratched up can effect the accuracy of the data it provides.2.Was there a surgical delay? if yes, what is the duration of the delay? no delay.
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 that 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: an analysis of the product could not be performed since a physical sample was not received for evaluation.An evaluation of the manufacturing record could not be performed as the required product identification number was not provided to complete the evaluation.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.However, if the product or product id numbers are received at a later date, the investigation will be updated as applicable.
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: staff reported sensor have become roughened and sharp and need replacing.The product was returned to j&j medtech orthopaedics for evaluation.Visual analysis of the returned device revealed that the cas ligament tensor size 2-xf had scratches on the surface.No other damage was observed.The potential cause of the observed condition can be attributed to user, as femoral cuts should not be made while the ligament tensor is in use.The scratches identified on the device are consistent with a saw blade making contact with it during operation.The attune® knee system patient specifc alignment tibia first surgical technique, page 49, specifies the following "utilize the ligament tensor to balance the knee" and that "prior to inserting the ligament tensor, it is imperative that the joint space is cleared of any loose tissue or debris, and the tibial cut is completed".A functional test was not performed since it was not applicable to the complaint condition.A dimensional inspection was not performed since it was not applicable to the complaint condition.The overall complaint was confirmed as the observed condition of the cas ligament tensor size 2-xf would have contributed to the complained issue.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of j&j medtech orthopaedics quality process, all devices are manufactured, inspected, and released to approved specifications.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: CAS LIGAMENT TENSOR SIZE 2-XF
• Common Device Name: KNEE INSTRUMENT: TENSIONING DEVICE
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 19720654
• Report Number: 1818910-2024-15027
• Device Sequence Number: 20869982
• Product Code: HWT
• UDI-Device Identifier: 10603295027072
• UDI-Public: (01)10603295027072(10)AB5091100
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: EXEMPT
• 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): 07/11/2024

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 Catalogue Number: 129901080
• Device Lot Number: AB5091100
• 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: 07/08/2024
• Supplement Date Received by Manufacturer: 07/19/2024; 08/23/2024; 09/23/2024; 12/19/2024
• Initial Report FDA Received Date: 07/11/2024
• Supplement Report FDA Received Date: 07/22/2024; 08/23/2024; 09/25/2024; 12/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/27/2021
• 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