MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 ACETAB PRESSURISER 52MM(5PACK); DEPUY CMW CEMENTING ACCESSORIES : CEMENT DELIVERY DEVICES

Catalog Number 3206052

Device Problems Break (1069); Crack (1135)

Patient Problem Not Applicable (3189)

Event Date 02/19/2019

Event Type  malfunction  

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Device was used for treatment, not diagnosis.

Event Description

It was reported that the acetabular pressure riser (p/n: (b)(4) was broken when it was attached to t handle for cementing the acetabular side during tha surgery on (b)(6) 2019.The surgery was completed by using the spare and there was within a 30 minutes surgical delay.There were no broken parts in the patient¿s body and there was no adverse consequence to the patient.No further information is available.

Manufacturer Narrative

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.Product complaint #: (b)(4).Investigation summary: the complaint states: ¿it was reported that the acetabular pressure riser (p/n: 3206052 (p)) was broken when it was attached to t handle for cementing the acetabular side during the surgery on (b)(6) 2019.The surgery was completed by using the spare and there was within a 30 minutes surgical delay.There were no broken parts in the patient¿s body and there was no adverse consequence to the patient.No further information is available.¿ the device was not returned, and no other evidence has been supplied to aid the investigation of the issue.It is possible that the t-handle could be twisted to insert into the acetabular silicone pressurizers and this could result in complex torsional, shear and tension forces, increasing the probability of pressurizer tear.Dfmea 103107375 rev 2 was reviewed, and this issue is included as a known hazard on lines 6,7,8 and 28.In each case the risk is considered ¿as low as possible¿ and cannot be further mitigated.A root cause cannot be determined with the information available currently.This is the first instance of this failure mode being reported in 12 months checked as part of the complaint review.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.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.Device history lot: device history cannot be reviewed as this product is manufactured externally.Device history batch: null.Device history review: null.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

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.H10 additional narrative: product complaint (b)(4).Investigation summary : the complaint states: ¿it was reported that the acetabular pressure riser (p/n: (b)(4).Was broken when it was attached to t handle for cementing the acetabular side during tha surgery on (b)(6) 2019.The surgery was completed by using the spare and there was within a 30 minutes surgical delay.There were no broken parts in the patient¿s body and there was no adverse consequence to the patient.No further information is available.¿ the device was returned for examination - see attachment "(b)(4).Photos.Pdf".There is a tear, approximately 2mm long, just above the second "0" in the product code reference number (b)(4).It is possible that the t-handle was twisted to insert into the acetabular silicone pressurisers and this could result in complex torsional, shear and tension forces, increasing the probability of pressuriser tear.Dfmea 103107375 rev 2 was reviewed, and this issue is included as a known hazard on lines 6,7,8 and 28.In each case the risk is considered ¿as low as possible¿ and cannot be further mitigated.A root cause cannot be determined with the information available currently.This is the first instance of this failure mode being reported in 12 months checked as part of the complaint review.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.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: ACETAB PRESSURISER 52MM(5PACK)
• Type of Device: DEPUY CMW CEMENTING ACCESSORIES : CEMENT DELIVERY DEVICES
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 8413179
• MDR Text Key: 138915498
• Report Number: 1818910-2019-87045
• Device Sequence Number: 1
• Product Code: JDZ
• Combination Product (y/n): N
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/19/2019

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 Catalogue Number: 3206052
• Device Lot Number: 60520353
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2019
• Initial Date Manufacturer Received: 02/19/2019
• Initial Date FDA Received: 03/12/2019
• Supplement Dates Manufacturer Received: 04/24/2019; 07/12/2019
• Supplement Dates FDA Received: 04/30/2019; 07/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1