MAUDE Adverse Event Report: DEPUY CMW - 9610921 VMP + DEPUY CMW 1 50G; BONE CEMENT : BONE CEMENT

Catalog Number 3002050

Device Problem Material Integrity Problem (2978)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The complaint states: ¿bone cement was damaged and physician couldn`t use them at all.No consequences for the patient reported.¿ the device was returned for investigation.The returned device was not in its original complete packaging.The transit cap for the syringe has fractured around 30% of its diameter.This confirms the complaint description.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that the cement was damaged and physician couldn`t use them at all.No consequences for the patient reported.

Manufacturer Narrative

Product complaint #
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> (b)(4) investigation summary
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> the complaint states: ¿bone cement was damaged and physician couldn`t use them at all.No consequences for the patient reported.¿ the device was returned for investigation (see attachment ¿(b)(4) photos.Pdf¿).The returned device was not in its original complete packaging.The transit cap for the syringe has fractured around 30% of its diameter.This confirms the complaint description.The fracture appears spiral and indicates possible overtightening during packing or additional stress during transit.Two new torque machines were installed and validated in 2017 under capa-002454.Em-014315 of capa-002454 confirms that complaints relating to transit caps in the 6 months after the new machines came online reduced by 80%.Dva-104409-fde rev 10 was reviewed, and this possible failure mode is included in lines 98 to 103 (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.There have been 0 other complaints for transit cap issues in the past 12 months.In conclusion this appears to be a random component failure, and it is not possible to determine root cause.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
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> device history reviewed: 0 non-conformances on this lot number.Final micro and sterility tests passed.All qc release specifications met.(b)(4) released.Lot expiry date: 30 november 2021 h10 additional narrative: added: d4 (expiration date).

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary
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> the device associated with this complaint was received for examination.Visual examination of the returned device found the ampule broken, incomplete packaging was received.As the packaging layer containing the liquid cement ampule was not returned it is not possible to determine or establish a root cause.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 necessary.Device history lot
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> a search of the depuy nonconformance (nc) quality system found two nonconformance recorded on this batch that was related to process controls and did not impact on the overall product.

• Brand Name: VMP + DEPUY CMW 1 50G
• Type of Device: BONE CEMENT : BONE CEMENT
• Manufacturer (Section D): DEPUY CMW - 9610921; cornford rd; blackpool FY4 4 QQ; UK FY4 4QQ
• Manufacturer (Section G): DEPUY CMW - 9610921; cornford rd; blackpool FY4 4 QQ; UK FY4 4QQ
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 12066665
• MDR Text Key: 258381663
• Report Number: 1818910-2021-13569
• Device Sequence Number: 1
• Product Code: LOD
• Combination Product (y/n): N
• Reporter Country Code: PL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2021
• Device Catalogue Number: 3002050
• Device Lot Number: 9264682
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/23/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1