MAUDE Adverse Event Report: BIOMET MICROFIXATION LACTOSORB 14 MM RAPIDFLAP CLAMP; BONE CLAMP

Model Number N/A

Device Problem Device Inoperable (1663)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/15/2016

Event Type  malfunction  

Manufacturer Narrative

Review of the device history records show that the lot was released with no recorded anomaly or deviation.The warnings in the package insert state this type of event can occur.The user facility is foreign; therefore a facility medwatch report will not be available.Current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.

Event Description

It is reported that during the excision of a cerebellum tumor, the clamp would not rotate.It is reported that there was no delay that exceeded 30 minutes; no foreign body remained in the patient; and there was no injury reported.

Manufacturer Narrative

The clamp was returned in bio hazardous condition, therefore only a visual inspection through the bag could be performed.The product identity has been confirmed.A visual evaluation revealed that the clamp is intact with no noticeable breaks.Due to the state of the clamp, no functional evaluation could be performed, therefore the complaint is non-verifiable.The most likely underlying cause of this complaint cannot be determined.The dhr (device history records) has been reviewed within the complaint and no non-conformances were found.There are no indications of manufacturing defects.

• Brand Name: LACTOSORB 14 MM RAPIDFLAP CLAMP
• Type of Device: BONE CLAMP
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer (Section G): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer Contact: michelle cole ; 1520 tradeport drive; jacksonville, FL 32218 ; 9047414400
• MDR Report Key: 5772206
• MDR Text Key: 48859793
• Report Number: 0001032347-2016-00321
• Device Sequence Number: 1
• Product Code: JEY
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: PK003281
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 06/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2020
• Device Model Number: N/A
• Device Catalogue Number: 915-0020
• Device Lot Number: 266620
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/13/2016
• Initial Date FDA Received: 07/06/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/22/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/22/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention