MAUDE Adverse Event Report: BIOMET MICROFIXATION 90° CONTRA ANGLE DRIVER; PLATE, BONE

Model Number	N/A
Medical Device Problem Code	Device Contamination with Body Fluid (2317)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/30/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet complaint (b)(4).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.It is unknown at this time if the device will be returned for evaluation.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 an instrument contained blood and tissue following the cleaning and sterilization process.Protein test was performed and the test result was positive.No adverse events were reported as a result of this malfunction.
Event or Problem Description
This follow-up report is being submitted to relay additional information.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The complaint was opened because (b)(6) , sales rep reports a screwdrivers with deposits of tissue and blood post sterilization.The four (4) 90 deg contra angle screwdrivr (part# 24-1189, lot# 474720, 129290, 449720, 003000) were returned for investigation.It was reported that the sterilization department opened the head of the screwdrivers (after cleaning and sterilization).According to the employee there were deposits of tissue and blood present.Protein test was performed and the test result was positive.Because the instruments were tested by the hospital with positive protein results, the complaint is considered confirmed.Visual evaluation showed all four of the contra angle drivers appeared to be in good overall condition.The drivers were disassembled for further inspection.The three drivers with lot numbers 474720, 129290, and 449720 were easily disassembled and were fairly clean internally, which would be consistent with the report that the drivers were cleaned, disassembled, and tested for protein.The fourth driver with lot number 003000 was returned with a contra angle blade (sp-2379) stuck inside the head assembly.This driver was difficult to disassemble and had lots of debris inside the head assembly.Following the report that protein was detected in the head assemblies of these drivers, validation #2019-57 - contra angle (24-1189) end user cleaning validation (includes us & ous parameters) was conducted.This cleaning validation proved that following the ifu's cleaning instructions eliminated all possibility of residual proteins within the instrument.The dhr's for these products were reviewed, no non-conformances were found.There are no indications of manufacturing defects.This is the only complaint regarding deposits of tissue and blood for this part# 24-1189, lot #'s 474720, 129290, 449720, and 003000.Therefore, the most likely underlying cause of the complaint is that the user did not follow the cleaning instructions detailed in the ifu.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.The following fields were updated: b4 date of this report b5 describe event or problem b4 lot number d10 device availability g4 date received by manufacturer g7 type of report h2 follow up type h3 device evaluated by manufacturer h4 device manufacturer date h6 method code h6 results code h6 conclusions code h10 additional narratives/data.

• Brand Name: 90° CONTRA ANGLE DRIVER
• Common Device Name: PLATE, BONE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 9263211
• Report Number: 0001032347-2019-00480
• Device Sequence Number: 14128958
• Product Code: HRS
• UDI-Device Identifier: 00841036123130
• UDI-Public: 00841036123130
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/09/2020

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: 24-1189
• Device Lot Number: 474720
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/01/2019
• Supplement Date Received by Manufacturer: 12/13/2019
• Initial Report FDA Received Date: 10/31/2019
• Supplement Report FDA Received Date: 01/10/2020
• 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