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

Catalog Number 2110-135-004

Device Problems Manufacturing, Packaging or Shipping Problem (2975); Appropriate Term/Code Not Available (3191)

Patient Problems No Patient Involvement (2645); No Information (3190)

Event Date 08/04/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Udi- (b)(4).Medical product - std brl lag scrw 12.5x120mm, item 236120, lot 2017030215.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: 3002806535-2018-001130.

Event Description

Hiploc plate and screw did not assemble.

Manufacturer Narrative

Zimmer biomet complaint (b)(4).Report source, foreign - event occurred in (b)(6).Multiple mdr reports were filed for this event, please see associated report: 3002806535-2018-001130-1.The product relating to the reported event has been returned to biomet uk ltd for evaluation.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.A review of the manufacturing history records for the hiploc plate from this event has not reported any abnormalities or deviations.13 complaints were previously recorded for this reported issue.A supplier corrective action report, scar- 01951, has been raised on sanatmetal to investigate their manufacturing processes in relation to the non-conformance.Product hold has been initiated: ph-2018-00225-emea.A corrective and preventative action, ca-04598 has been raised to investigate receipt and release of product.A health hazard evaluation has been completed (hhe-2018-00210), resulting in a field action determination: zfa-2018-00210.

Event Description

Hiploc plate and screw does not assemble.

• Brand Name: STD BRL 4-HOLE PLATE 135 DEG
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 7951493
• MDR Text Key: 123371939
• Report Number: 3002806535-2018-01129
• Device Sequence Number: 1
• Product Code: JDO
• Combination Product (y/n): N
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 03/06/2019

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: 2110-135-004
• Device Lot Number: 6224834
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/18/2018
• Initial Date FDA Received: 10/10/2018
• Supplement Dates Manufacturer Received: 09/18/2018
• Supplement Dates FDA Received: 03/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 3002806535
• Patient Sequence Number: 1