MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP PENDING; PIN, TEMP FIX, THREADED MINI, 1.1 X 10MM

Model Number	MMPF1110T
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/23/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the facility during a procedure the 'bb taks broke inside the patient and the doctor had to remove them'.According to the facility the doctor was able to remove the broken pieces and the procedure was completed without further issue.The sample was not returned for evaluation.No additional information is available.Due to the reported incident and in an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
Event or Problem Description
According to the facility during a procedure the 'bb taks broke inside the patient and the doctor had to remove them'.

• Brand Name: PENDING
• Common Device Name: PIN, TEMP FIX, THREADED MINI, 1.1 X 10MM
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: justin herrmann ; three lakes drive; northfield, IL 60093
• MDR Report Key: 14160651
• Report Number: 1417592-2022-00054
• Device Sequence Number: 2847744
• Product Code: LHX
• UDI-Device Identifier: 10080196690886
• UDI-Public: 10080196690886
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/20/2022

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: MMPF1110T
• Device Catalogue Number: MMPF1110T
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/06/2022
• Initial Report FDA Received Date: 04/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 52 YR
• Patient Sex: Female