MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP MEDLINE; SCREW, CROSSPLATE, 3.5 X 34MM

Model Number	MPP2200R
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/12/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that the patient had a lapidus procedure performed on (b)(6) 2021 at which time the hardware was implanted into his foot.The patient is in a walking boot and during recovery experienced a fall.The patient was seen in the clinic by the doctor on (b)(6) 2021 and upon assessment it was noted that the cross plate screw was backing out of the lapidus plate.After additional tests were performed it was determined that the bones have fused and the patient is doing well so the surgeon brought the patient back in to the office on (b)(6) 2021 to remove the screw from the foot in the office.The surgeon made a small incision and removed the screw from the patient in the clinic without further incident or injury.The surgeon noted that the bones have fused and the patient is doing well.The sample has not been returned to the manufacturer as of the filing of this report.Due to the reported incident and in an abundance of caution, this medwatch is being filed.If additional relevant information becomes available a supplemental medwatch will be filed.
Event or Problem Description
It was reported that the cross plate screw was backing out of the lapaidus plate in the patients foot requiring removal by the clinician.
Additional Manufacturer Narrative
Corrected information: d4- common device name: screw, crossplate, 3.5 x 34mm product code: hwc catalog number- mpsx3534 additional information: d4-lot #-586095 d9-yes h6 sample received 3/21/2022 the customer returned the sample for evaluation.The actual product code was determined to be mpsx3534 (screw) not the mpp2200r (plate) initially reported.It was reported that the cross plate screw was backing out of a dual mode lapidus right plate (mpp2200r) after it was implanted.A visual, functional and dimensional evaluation was performed and the customer reported issue was confirmed however a definitive root cause was not able to be determined.Due to the reported incident and in an abundance of caution, this medwatch is being filed.If additional relevant information becomes available a supplemental medwatch will be filed.

• Brand Name: MEDLINE
• Common Device Name: SCREW, CROSSPLATE, 3.5 X 34MM
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: karen trutsch ; three lakes drive; northfield, IL 60093
• MDR Report Key: 13001018
• Report Number: 1417592-2021-00217
• Device Sequence Number: 14494148
• Product Code: HWC
• UDI-Device Identifier: 10888277691568
• UDI-Public: 10888277691568
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/23/2022
• 2 Devices were Involved in the Event: 1 2

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: MPP2200R
• Device Catalogue Number: MPSX3534
• Device Lot Number: 586095
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/15/2021
• Supplement Date Received by Manufacturer: 03/21/2022
• Initial Report FDA Received Date: 12/14/2021
• Supplement Report FDA Received Date: 03/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 50 YR
• Patient Sex: Male
• Patient Race: White