MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 SMARTSET GHV GENTAMICIN 40G; BONE CEMENT : BONE CEMENT

Catalog Number 3095040

Device Problems Device Damaged Prior to Use (2284); Packaging Problem (3007)

Patient Problem Not Applicable (3189)

Event Date 07/11/2019

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

Tkr: dr (b)(6).After opening box, cement pouch was not sealed and powder falling out as per attached image.New packets opened.No ae to the patient, 5 minutes delay to the surgery.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provision depuy synthes 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).The complaint states: ¿tkr: dr sorial, nepean public hospital.After opening box, cement pouch was not sealed and powder falling out as per attached image.New packets opened.No ae to the patient, 5 minutes delay to the surgery.¿ a review of the photographs supplied with this complaint confirm the complaint description (see attachment ¿(b)(4) customer photos.Pdf¿).The supplier seal has breached at the bottom, right hand side of the powder bag.The breach is approximately 10-12mm in length and is present all the way across the seal area.The filling of powder bags is a manual process, and any failure of the supplier seal would be observed either during packing at powder fill, or during the final packaging preparation stage where the powder bag and sterile barrier are placed in a protective moisture barrier.3 retained samples were examined for this failure but no further instances were uncovered.Dva-107020-fde rev 9 was reviewed, and this failure mode is included on line 103 (see attachment ¿(b)(4) extract from dva-107020-fde.Pdf¿).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.Device history lot : device history reviewed 09 oct 19 2 unrelated non-conformances on this lot number.Final micro and sterility tests passed.(b)(4) units released.Expiry date: 30 apr 20 device history batch : null.Device history review : null.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: SMARTSET GHV GENTAMICIN 40G
• Type of Device: BONE CEMENT : BONE CEMENT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw 46582
• MDR Report Key: 8836448
• MDR Text Key: 152796475
• Report Number: 1818910-2019-99521
• Device Sequence Number: 1
• Product Code: MBB
• 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: 07/11/2019

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 Expiration Date: 04/30/2020
• Device Catalogue Number: 3095040
• Device Lot Number: 8801948
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/11/2019
• Initial Date FDA Received: 07/29/2019
• Supplement Dates Manufacturer Received: 10/09/2019
• Supplement Dates FDA Received: 10/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1