MAUDE Adverse Event Report: BIOMET UK LTD. STD BRL 4-HOLE PLATE 135 DEG; DEVICE, FIXATION

Model Number N/A

Device Problem Difficult to Insert (1316)

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

Event Date 12/12/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It has been reported that during a procedure, the lag screw would not fit through the barrel of the hiploc plate.Another new plate and the same lagscrew was used to complete the procedure.

Manufacturer Narrative

(b)(4).The product relating to the reported event has been returned to biomet uk ltd for evaluation and below is the investigation details.Visual checks: on receiving the ¿hiploc plate¿ and ¿hiploc lag screw¿ a visual check was performed with the following observations found:- hiploc plate ¿ various scratches and marking from handling and attempted implantation.¿ etching is clear.Hiploc lag screw ¿ various scratches and marking from handling and attempted implantation.¿ etching is clear.Document review: a review of the manufacturing history records for the hiploc plate from this event has not reported any abnormalities or deviations.Complaints : 13 complaints have been recorded for a similar issue,.The returned hiploc plates have been confirmed as non-conforming.The internal barrel on the hiploc plate has been confirmed as undersize through dimensional checks.The hiploc lag screws in all returned product have been confirmed as conforming to pre-defined specification when manufactured, and require no further action to be taken.A supplier corrective action report, has been raised on sanatmetal to investigate their manufacturing processes in relation to the non-conformance.The risk assessment residual score has increased and will be considered by the product engine management team as part of a health hazard evaluation hhe2018-00210.

• Brand Name: STD BRL 4-HOLE PLATE 135 DEG
• Type of Device: DEVICE, FIXATION
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• Manufacturer (Section G): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 7137234
• MDR Text Key: 95644537
• Report Number: 3002806535-2017-01219
• Device Sequence Number: 1
• Product Code: JDO
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/15/2018

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 Model Number: N/A
• Device Catalogue Number: 2110-135-004
• Device Lot Number: 6097551
• Other Device ID Number: SEE H10
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/12/2017
• Initial Date FDA Received: 12/21/2017
• Supplement Dates Manufacturer Received: 06/15/2018
• Supplement Dates FDA Received: 06/15/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/19/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1