MAUDE Adverse Event Report: DEPUY CMW - 9610921 SMARTSET GHV GENTAMICIN 40G; BONE CEMENT : BONE CEMENT

Catalog Number 3095040

Device Problem Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/07/2020

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

Box of smartset ghv was opened for total knee replacement.The sterile packaging holding the vial of fluid was warped and the contents inside the packaging appeared to be a green colour.

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.Dmf# - (b)(4), trade name ¿ gentamicin sulphate, active ingredient(s) ¿ gentamicin sulphate, dosage form - powder, strength ¿ 1.0g active in our cements.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.No 510k as device is not marketed in the united states under this product code, but the same/similar product is marketed in the us under a different product code.

Manufacturer Narrative

Product complaint #
=
> (b)(4).Investigation summary
=
> the complaint states: ¿box of smartset ghv was opened for total knee replacement.The sterile packaging holding the vial of fluid was warped and the contents inside the packaging appeared to be a green colour.¿ the photographs supplied by the hospital confirm the product details and show a discoloured ampoule pack still containing an ampoule.The discolouration of the packaging and warping of the lid indicate exposure to monomer and infer that the ampoule has been damaged.The photographs confirm the complaint description.There is insufficient information to determine possible root cause.Retained samples from this lot number were checked for signs of this failure mode, but no further broken ampoules were discovered.Fmea dva-107020-fde rev 10 includes references to this failure mode (see attachment ¿(b)(4)extract from dva-107020-fde.Pdf¿.In each case the risk is considered ¿as low as possible¿ and cannot be further mitigated.In conclusion, this is a known failure mode and the current rate of complaints for this issue is within the expected occurrence rate 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: 4 unrelated non-conformances on this lot number.Final micro and sterility tests passed.Qc release specifications met 4250 units released lot expiry date: 31 may 2021.

• Brand Name: SMARTSET GHV GENTAMICIN 40G
• Type of Device: BONE CEMENT : BONE CEMENT
• Manufacturer (Section D): DEPUY CMW - 9610921; cornford rd; blackpool FY4 4 QQ; UK FY4 4QQ
• MDR Report Key: 10726126
• MDR Text Key: 212713550
• Report Number: 1818910-2020-23163
• Device Sequence Number: 1
• Product Code: MBB
• Combination Product (y/n): N
• PMA/PMN Number: K081163
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 10/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2021
• Device Catalogue Number: 3095040
• Device Lot Number: 9207054
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1