MAUDE Adverse Event Report: BIOMET UK LTD. 12.5MM LAG SCREW; DEVICE, FIXATION

Model Number N/A

Device Problem Difficult To Position (1467)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/15/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).(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 reports: 3002806535-2017-00952.

Event Description

It was reported that during a procedure, the lag screw could not be passed through the barrel of the plate.Another lag screw and plate were used to complete the procedure.

Manufacturer Narrative

(b)(4).Products were returned to biomet uk ltd for evaluation and investigation details are as follows: summary of investigation: 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: the below ¿manufacturing history records¿ were reviewed.Mhr 3918338 std brl 4-holes plate 135 deg.12 devices produced and packaged.12 items were reworked for incomplete is sheet.12 items were then accepted at the completion of manufacturing.Mhr 2016040531 std brl lag scrw 12.5x125mm.12 devices produced and packaged.No non-conformities scrap or rework.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, scar- 01951, has been raised on the manufacture 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: 12.5MM LAG SCREW
• Type of Device: DEVICE, FIXATION
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 6955618
• MDR Text Key: 90541321
• Report Number: 3002806535-2017-00953
• Device Sequence Number: 1
• Product Code: JDO
• Combination Product (y/n): N
• PMA/PMN Number: PK080685
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 05/16/2018

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: Physician
• Device Model Number: N/A
• Device Catalogue Number: 236100
• Device Lot Number: 2016110033
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/18/2017
• Initial Date FDA Received: 10/17/2017
• Supplement Dates Manufacturer Received: 05/15/2018
• Supplement Dates FDA Received: 05/16/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: HIPLOC SYSTEM PLATE PN:2110-135-004 LN:3902251.