MAUDE Adverse Event Report: BIOMET MICROFIXATION LACTOSORB SYSTEM 1.5MM ADJUSTABLE SELF-DRILLING TAP; TAP, BONE

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet (b)(4).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.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: 0001032347-2021-00006.Medical products: 1.5mm system twist drill with j notch 1.1 x 50mm, 9mm stop, part# 01-7146, lot# ni; lactosorb system 1.5mm adjustable self-drilling tap, part# 915-1595, lot# ni.The user facility is foreign; therefore, a facility medwatch report will not be available.Report source ¿ (b)(6).
Event or Problem Description
It was reported the tap broke while the surgeon was cutting the tap resulting in a surgical delay greater than thirty minutes.The surgeon drilled a hole around the broken tap with a twist drill and used pliers to remove the tap.Imaging revealed there was no fragment in the patient's body.No additional patient consequences have been reported.
Additional Manufacturer Narrative
Lot # was identified to be either: 740230, 978400, 240790, 240800, 312840, 886060, 041940, 161330, 442760, 645150, 645160.
Event or Problem Description
No further event information is available at the time of this report.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
The 1.5 mm lacto adj sd tap (item# 915-1595, lot# 554064) was returned for investigation.It was determined that the '554064' etched on the body of this drill is the vendor's lot.Based on a review of inventory transactions and the customer's purchase history, there are 11 possible zimmer biomet lots: 041940, 161330, 240790, 240800, 312840, 442760, 645150, 645160, 740230, 886060, or 978400.Visual examination of the returned drill and tap confirmed the products' identity.It was also confirmed that the drill and tap were fractured, near the neck at the start of the fluted section.Review of the device history records identified no deviations or anomalies during manufacturing.The supplier dhr for the tap was not requested because the raw material certificate showed material is conforming to specification.From the potential manufacturing dates, the instrument has a possible field age of more than 7 years.The device also shows wear and tear, possibly indicating repeated use.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: LACTOSORB SYSTEM 1.5MM ADJUSTABLE SELF-DRILLING TAP
• Common Device Name: TAP, BONE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 11121466
• Report Number: 0001032347-2021-00007
• Device Sequence Number: 18990588
• Product Code: HWX
• UDI-Device Identifier: 00888233012027
• UDI-Public: 00888233012027
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/16/2021

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
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 915-1595
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/15/2020
• Supplement Date Received by Manufacturer: 07/02/2021; 07/16/2021
• Initial Report FDA Received Date: 01/05/2021
• Supplement Report FDA Received Date: 07/09/2021; 07/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: TW DRILL 1.1X50MM 9MM CAT#:01-7146 LOT#:250370.
• Outcome Attributed to Adverse Event: Required Intervention