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

Catalog Number 3095040

Device Problem Device Damaged Prior to Use (2284)

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

Event Date 11/06/2020

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Details for gentamicin component of combination product: dmf# - 13704, 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 medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

When opening the device, it was noticed that it was defective.

Event Description

Additional information received stating that at the opening, the health team noticed that the product have flowed in the packaging.

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.H10 additional narrative: added: b5.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected: b3.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : the complaint states: ¿when opening the device, it was noticed that it was defective.Additional information received: no patient consequences following the issue.At the opening, the health team noticed that the product have flowed in the packaging.Another device has been used.¿ there are two components included in each unit carton (powder in a bag and liquid in a glass ampoule) and it is not possible to determine the nature of the failure from the information supplied in the complaint description and additional information.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: 0 non-conformances on this lot number.Final micro and sterility tests passed.All qc release specifications met.(b)(4) units released.Lot expiry date: 31 october 2021.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: the complaint states: ¿when opening the device, it was noticed that it was defective.Additional information received: no patient consequences following the issue.At the opening, the health team noticed that the product have flowed in the packaging.Another device has been used.¿ the sample was received for investigation (see attachment ¿(b)(4) photos.Pdf¿).The returned ampoule has broken at the bottom and resulted in monomer leaking into the ampoule blister packaging.This examination confirms the complaint description.There is no evidence that the outer packaging of the unit has sustained any relevant damage.Retained samples for this lot number were examined with no further examples of this failure mode discovered.There is insufficient information to determine possible root cause.(b)(4) rev 10 was reviewed, and this possible failure mode is included (see attachment ¿(b)(4) extract from (b)(4).Pdf¿).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: 0 non-conformances on this lot number.Final micro and sterility tests passed.All qc release specifications met.(b)(4) units released.Lot expiry date: 31 october 2021.

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.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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: SMARTSET GHV GENTAMICIN 40G
• Type of Device: BONE CEMENT : BONE CEMENT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 11006845
• MDR Text Key: 225344008
• Report Number: 1818910-2020-26923
• Device Sequence Number: 1
• Product Code: MBB
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 11/27/2020

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: 3095040
• Device Lot Number: 9353886
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2021
• Initial Date Manufacturer Received: 11/27/2020
• Initial Date FDA Received: 12/15/2020
• Supplement Dates Manufacturer Received: 02/05/2021; 02/23/2021; 04/15/2021; 06/08/2021
• Supplement Dates FDA Received: 02/16/2021; 02/23/2021; 05/11/2021; 06/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1