MAUDE Adverse Event Report: BIOMET UK LTD. STD BRL 8-HOLE PLATE 135 DEG; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number N/A

Device Problems Delivered as Unsterile Product (1421); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Report source, foreign - event occurred in (b)(6).Customer has indicated that the product is in the process of being returned to zimmer biomet for investigation.Once the investigation is complete, a supplemental mdr will be submitted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported by the hospital that the internal sterile packaging was damaged.Subsequently, another device had been used for the surgery.

Manufacturer Narrative

(b)(4).This report is being submitted to relay additional information.The following sections were updated: b4, b5, d10, g4, h1, h2, h3, h6, h10.The event reports that the outer sterile packaging was damaged (outer pouch of a double pouch sterile barrier system).The reported event was identified during surgery.No harm, including extension to surgery, has been reported.The reported event has been confirmed through visual inspection of the returned packaging, which confirms that the outer sterile barrier has been breached.A review of the device history records did not identify any discrepancies that would have contributed to the reported event.A complaint search identified no similar complaints for the same part number, and no further complaints for the same lot number.The assessed severity and occurrence of the reported event has not exceeded the recorded severity and occurrence on the relevant line in the risk management file.The likely condition of the device when it left zimmer biomet is conforming to specification.The root cause of the reported event is likely to be damage caused by the transit process.No corrective action required.No harm has been reported (reported event has a severity score of 1), and there is no indication that other units in the field are affected.No manufacturing or design issue has been identified.This device is no longer manufactured by the uk.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.

Event Description

It was reported that the inner sterile packaging was damaged.Subsequently, another device was used for the surgery.

• Brand Name: STD BRL 8-HOLE PLATE 135 DEG
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 8748053
• MDR Text Key: 205085846
• Report Number: 3002806535-2019-00554
• Device Sequence Number: 1
• Product Code: JDO
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 02/20/2020

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 Expiration Date: 09/30/2020
• Device Model Number: N/A
• Device Catalogue Number: 2110-135-008
• Device Lot Number: 2120637
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/06/2019
• Initial Date FDA Received: 07/01/2019
• Supplement Dates Manufacturer Received: 01/30/2020
• Supplement Dates FDA Received: 02/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1