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

Catalog Number 2110-135-004

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/19/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4) medical device: unknown screw.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 reports: 3002806535-2018-01077.

Event Description

Hiploc plate and screw does not assemble.

Event Description

The hole is too small so you can´t get the screw though the hole.

Manufacturer Narrative

(b)(4).The product relating to the reported event has been returned to (b)(4) for evaluation.A review of the manufacturing history records for the hiploc plate from this event has not reported any abnormalities or deviations.A review of the complaint database found 17 similar complaints reported for this item code.The returned hiploc plates have been confirmed as non-conforming.The internal barrel on the hiploc plate has been confirmed as undersized through dimensional checks.A supplier corrective action report, (b)(4), has been raised on sanatmetal to investigate their manufacturing processes in relation to the non-conformance.A capa, (b)(4) has been raised to investigate receipt and release of product.Product hold has been initiated: (b)(4).A hhe has been completed: (b)(4).A field action determination has been completed: zfa-2018-00210.

• 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: 7874837
• MDR Text Key: 120705083
• Report Number: 3002806535-2018-01078
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/12/2018

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 Catalogue Number: 2110-135-004
• Device Lot Number: 6239135
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/17/2018
• Initial Date FDA Received: 09/13/2018
• Supplement Dates Manufacturer Received: 12/11/2018
• Supplement Dates FDA Received: 12/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: ZFA-2018-00210
• Patient Sequence Number: 1