MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC. PENDING; PIN, TEMP FIX, SMOOTH MINI, 1.1 X 10MM

Model Number	MMPF1110
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/08/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported by a facility that a patient was undergoing an open reduction with internal fixation (orif) for a fifth metatarsal avulsion fracture.The facility stated that the first non-threaded wire end broke off as the doctor was securing the fifth metatarsal plate jig through the jig wire holes.The second wire end broke off as the doctor was placing the non-threaded wire to secure the distal end of the plate.According to the reporter the bone looked healthy and hard.The reporter stated no excessive force was applied.Reportedly the ends of the broken wires remain in the patient's fifth metatarsal and are visible on x-ray.The doctor made the determination that it would have caused more damage to try to retrieve the broken wires.The patient was under anesthesia, however, no additional anesthesia or medication was required.There was no report of any adverse patient consequence and no effect on the patient's stability as a result of the incident.There were no complications noted with the patient during or after the procedure.The actual device remains in the patient and is not going to be returned to the manufacturer for evaluation.Due to the reported incident and in an abundance of caution this is an mdr reportable event.No additional information is available.If additional information becomes available, this report will be re-opened and re- evaluated.No additional information is available.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 wires broke while being secured.The ends of the broken wires remain in the patient's foot due to the benefit outweighing the risk of removal.

• Brand Name: PENDING
• Common Device Name: PIN, TEMP FIX, SMOOTH MINI, 1.1 X 10MM
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• MDR Report Key: 10568003
• Report Number: 1417592-2020-00108
• Device Sequence Number: 11403577
• Product Code: LXH
• UDI-Device Identifier: 10888277690875
• UDI-Public: 10888277690875
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/10/2020

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: MMPF1110
• Device Catalogue Number: MMPF1110
• Device Lot Number: MPKIT003D
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/10/2020
• Initial Report FDA Received Date: 09/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 40 YR
• Patient Weight: 64