MAUDE Adverse Event Report: BIOMET MICROFIXATION LACTOSORB ADJUSTABLE SELF DRILLING TAP

Model Number N/A

Device Problems Break (1069); Use of Device Problem (1670)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

The package insert states "the patient is to be warned by his physician of all surgical risks, including the risk of fracture or breakage.Instruments are available to aid in the accurate implantation of internal fixation devices.Intraoperative fracture or breakage of surgical instruments in general has been reported.Instruments which have experienced extensive use or excessive force are susceptible to fracture.Surgical instruments should only be used for their intended purpose." current information is insufficient to permit a valid conclusion about the cause of this event.A follow-up report will be sent upon completion of the device evaluation.

Event Description

It is reported the lactosorb tap broke during cranial surgery.The broken piece was retrieved and no adverse events were reported.

Manufacturer Narrative

This part could potentially be from one of five possible lots, the device history records were reviewed for these potential lots and no non-conformances were identified that would cause or contribute to the event.Visual inspection of the returned instrument confirmed that the tap is broken and does not function as intended.The tip of the tap fractured along the threads.The fractured portion of the tip exhibits deformation along the threads which may be indicative of the attempt to remove the tip from the patients bone by drilling the area around the tap, as stated in the complaint.There are no indications of manufacturing defects.Functional tests could not be performed due to the extent of the damage of the tap.The ifu (instructions for use) warns against using excessive force; "instruments which have experience extensive use or excessive force are susceptible to fracture.Surgical instruments should only be used for their intended purpose." the most likely underlying root cause is that the excessive force was applied while the tap was inserted into the bone.

• Brand Name: LACTOSORB ADJUSTABLE SELF DRILLING TAP
• Type of Device: SELF DRILLING TAP
• 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: 4961118
• MDR Text Key: 23324229
• Report Number: 0001032347-2015-00327
• Device Sequence Number: 1
• Product Code: HWX
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 07/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2015
• 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: 915-1595
• Device Lot Number: UNKNOWN
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/21/2009
• 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