MAUDE Adverse Event Report: BIOMET MICROFIXATION LACTOSORB SYSTEM LACTOSORB DIRECT DRIVER BLADE; SCREWDRIVER

Model Number	N/A
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/26/2020
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: 0001032347-2020-00433, 0001032347-2020-00434.Lot number: based on a review of inventory transactions and the customer's purchase history, there are two (2) possible lots: 061150, 394730.Medical products: lactosorb system lactosorb direct driver blade, part# 915-2451, serial# 392193, possible lot# 745970, 329600, 195230; lactosorb system lactosorb direct driver blade, part# 915-2451, lot# 572419; lactosorb system lactosorb direct driver blade, part# 915-2451, serial# 475276, possible lot# 061150, 394730; 2.0 lactosorb system 2.0 x 5 mm direct drive screw, part# 915-2200, lot# n; 2.0 lactosorb system 2.0 x 7 mm direct drive screw, part# 915-2201, 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 that multiple blades were unable to retain screws during a surgical procedure.The five (5) mm screws could be grasped and the seven (7) mm screws could not be grasped.The procedure was completed with alternate blades.No adverse events were reported as a result of the malfunction.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.
Event or Problem Description
It was reported that multiple blades were unable to retain screws during an upper and lower osteotomy.The five (5) mm screws could be grasped and the seven (7) mm screws could not be grasped.The procedure was completed with alternate blades.No adverse events were reported as a result of the malfunction.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected: b4; b5; g3; g6; h1; h2; h3; h6.A visual inspection was conducted on the returned blades.The blades showed signs of general use but no visible damage was present.All three orientations were checked and the fits met all specifications.The blades are functioning as they should.Medical records were not provided.A review of the device history records was not performed as the returned items functioned as intended.No problem was found with product.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.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: LACTOSORB SYSTEM LACTOSORB DIRECT DRIVER BLADE
• Common Device Name: SCREWDRIVER
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 10529187
• Report Number: 0001032347-2020-00435
• Device Sequence Number: 11568718
• Product Code: HXX
• UDI-Device Identifier: 00841036055714
• UDI-Public: 00841036055714
• 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): 03/18/2021

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
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 915-2451
• Device Lot Number: SEE H10 NARRATIVE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/27/2020
• Supplement Date Received by Manufacturer: 09/01/2020; 03/18/2021
• Initial Report FDA Received Date: 09/14/2020
• Supplement Report FDA Received Date: 09/15/2020; 03/24/2021
• 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