MAUDE Adverse Event Report: BIOMET MICROFIXATION STERILETRAC SYSTEM X-DRIVE THINFLAP 2 HOLE STRAIGHT PLATE; PLATE, BONE

Model Number	N/A
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that non-conforming goods were discovered in the distributor's warehouse in (b)(6) 2021.Subsequently, the issue has been identified as foreign material in the package.
Additional Manufacturer Narrative
Zimmer biomet complaint (b)(4).Concomitant medical products: item sp-st5-6704, lot # 221500, sterile trac system sterile trac 5 xd thinflap 1.5 x 4.0mm screw.Report source: foreign: (b)(6).A visual inspection was conducted on the returned product per inspection criteria.The packaging was then opened to further investigate the total pieces of debris and a single hair could be seen inside the sterile pack.The complaint is confirmed.Review of the device history record(s) identified no deviations or anomalies during manufacturing.Root cause is attributed to a manufacturing issue.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.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2022-00051.

• Brand Name: STERILETRAC SYSTEM X-DRIVE THINFLAP 2 HOLE STRAIGHT PLATE
• Common Device Name: PLATE, BONE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer (Section G): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer Contact: christina arnt ; 1520 tradeport drive; jacksonville, FL 32218 ; 9047414400
• MDR Report Key: 13509728
• Report Number: 0001032347-2022-00050
• Device Sequence Number: 14731229
• Product Code: JEY
• UDI-Device Identifier: 00888233007573
• UDI-Public: (01)00888233007573(17)260223(10)068020
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K953385
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/10/2022

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 Expiration Date: 02/23/2026
• Device Model Number: N/A
• Device Catalogue Number: 25-1005X
• Device Lot Number: 068020
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2021
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/20/2022
• Initial Report FDA Received Date: 02/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/23/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• 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
• Patient Sex: Unknown