MAUDE Adverse Event Report: BIOMET UK LTD. RHK 71X10 RM/LL STR TIB AUG AUGMNT

Catalog Number 161558

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

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/25/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4) - report source, foreign - event occurred in (b)(6).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

During surgery it has been noticed that the inner bag of the augment packaging was damaged.The augment was still implanted.

Event Description

During surgery it has been noticed that the inner bag of the augment packaging was damaged.The augment was still implanted.

Manufacturer Narrative

(b)(4).The packaging was returned to biomet uk ltd for evaluation and forwarded to the complaints and vigilance engineer for investigation.Visual inspection confirmed the reported event.The plastic pouch has been torn.The tear is clean and sharp, indicating that it was caused by a sharp edge.The factors that could contribute to the defect are: friction between the pouch surface and the edge of the implant.The plastic pouch could have been stretched on the item as the air from the package was being extracted prior to vacuum sealing the package.The tension force would have caused creep over the time and micro cracks.However, the exact root cause could not be determined.The manufacturing history record related to the involved product has been reviewed and does not show any non-conformity, rejection or concession that could be related to the reported event.A review of the complaint database over the last 3 years has found no similar complaints reported with these items.The complaints database will be continued to be monitored.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: RHK 71X10 RM/LL STR TIB AUG AUGMNT
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 7805717
• MDR Text Key: 118247115
• Report Number: 3002806535-2018-01016
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 05/23/2019

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: 161558
• Device Lot Number: 3957148
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/25/2018
• Initial Date FDA Received: 08/22/2018
• Supplement Dates Manufacturer Received: 05/22/2019
• Supplement Dates FDA Received: 05/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1