MAUDE Adverse Event Report: BIOMET UK LTD. MLRY-HD RNGLC SHL 48MM/L22

Model Number N/A

Device Problem Device Damaged Prior to Use (2284)

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

Event Date 01/15/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Concomitant medical product: mlry-hd rnglc shl 56mm/l24, item 104156, lot 3388004.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.Multiple mdr reports were filed for this event, please see associated report: 3002806535-2018-00177.

Event Description

It was reported that inner pouches were damaged.

Manufacturer Narrative

(b)(4).Products have been returned to biomet (b)(4) for evaluation and forwarded to the complaints and vigilance engineer for investigation.Summary of investigation: visual checks: on receiving the mallory shell from zimmer biomet (b)(4), the following observations have been found: the device pouch is damaged on all returned devices, where the device fin has created a hole in the pouch.No damage has been found on the external wall of the blister.Scoring on the internal wall of the blister has been found.No damage has been found on the internal wall of the cardboard carton.Foam particles are evident on the pouch on all returned devices.All primary sterile barriers (tyvek to blister seal) are complete and not damaged.All labelling information is correct.The returned devices were within their defined shelf life.I.E.Not expired.Documentation review: the manufacturing records have been checked for manufacturing review, rework and scrap activities.With the following observations: 3541094: 6 devices on manufacturing run.All devices have been packaged with no deviation, scrap or rework recorded or found.388004: 6 devices on manufacturing run.All devices have been packaged with no deviation, scrap or rework recorded or found.Bill of materials on sap has been checked against the manufacturing history record with no deviations found.The devices have been visually examined which has concluded that damage to the implant pouch has occurred most likely due to the fins breaking through the pouch, and as a result, compromising the secondary sterile barrier.An increase in complaints received prompted further investigation and as a result, a hhed was initiated to assess patient risk.A risk assessment using product sales verses complaints has been completed and has confirmed the risk has not been exceeded and therefore there is no risk to patient safety.A new revised packaging configuration went live on the 14th march 2016 to update the packaging of the mallory shell devices.However, the devices returned for this product evaluation were packaged using the old configuration due to the manufacturing date pre-dating the new packaging which went live in march 2016.No complaints for damaged packaging have been recorded for the new packaging configuration.It can be concluded that the devices returned in this evaluation were conforming to pre-defined packaging specification.

• Brand Name: MLRY-HD RNGLC SHL 48MM/L22
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 7218000
• MDR Text Key: 98603882
• Report Number: 3002806535-2018-00176
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• PMA/PMN Number: PNI
• 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: 08/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 104148
• Device Lot Number: 3541094
• Other Device ID Number: SEE H10
• Date Manufacturer Received: 07/11/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1