MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 UNK CEMENT DELIVERY DEVICE

Catalog Number UNK CEMENT DELIVERY DEVICE

Device Problem Break (1069)

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

Event Date 11/11/2020

Event Type  malfunction  

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 Description

The primary surgery was performed via tka with another company's implants on (b)(6) 2020.It was reported that during the surgery, when the staff prepared the cement, the projection part to connect the tube of mixing paddle broke and could not be connect the tube.The surgery was completed with backup devices without any surgical delay.There was no harm to the patient.No further information is available.

Manufacturer Narrative

Product complaint #
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> (b)(4) investigation summary
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> the complaint states: ¿the primary surgery was performed via tka with another company's implants on (b)(6) 2020.It was reported that during the surgery, when the staff prepared the cement, the projection part to connect the tube of mixing paddle broke and could not be connect the tube.The surgery was completed with backup devices without any surgical delay.There was no harm to the patient.No further information is available." as the sample was not returned for examination, the complaint description describes the connector on the mixing lid breaking away from the lid when the staff attached the tube from the foot-pump.No photographs or other evidence has been supplied to support the complaint description.The complaint description cannot be confirmed and there is insufficient information to determine root cause.Dva-104409-fde rev 10 was reviewed and this possible failure mode is included on lines 136-145 (see attachment ¿(b)(4) extract from dva-104409-fde.Pdf¿).In each case the risk is considered as low as possible and cannot be further mitigated.No information received with this individual complaint indicated that a broader investigation or corrective action was necessary the number of complaints received for this failure mode will continue to be monitored and product updates/ recommendations will be implemented at the post market surveillance review dependent upon occurrence ratings.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 required.

• Brand Name: UNK CEMENT DELIVERY DEVICE
• Type of Device: CEMENT DELIVERY DEVICE
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• MDR Report Key: 10923831
• MDR Text Key: 219311785
• Report Number: 1818910-2020-25715
• Device Sequence Number: 1
• Product Code: KIH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK CEMENT DELIVERY DEVICE
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: VMP ENDURANCE 80G