MAUDE Adverse Event Report: WESTMED LLC FLEX EXTENDERS; FLEX EXTENDERS 5.2

Model Number	7-5132
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/22/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The actual complaint product was not returned for evaluation.The device history record for lot: 0004289133 was reviewed and the product was produced according to product specifications.All information reasonably known as of 20 sep 2024 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by sun med holdings llc.Represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to sun med holdings llc.Sun med holdings llc.Has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the sun med holdings complaint database and identified as complaint (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that an sun med holdings llc.Product is defective or caused serious injury.
Event or Problem Description
Sunmed holdings llc.Received a single report that referenced three different incidences, which were associated with separate units, involving three different patients.This is the first of three reports.Refer to 2028807-2024-00047 for the second report.Refer to 2028807-2024-00048 for the third report.It was reported, the clear piece came apart during the procedure; there was no reported injury.
Additional Manufacturer Narrative
Correction: d5.Additional information: h2; h3; h6.A representative sample from the reported event was returned and processed for evaluation.During setup, of the device, for evaluation the connector fell out; during testing, the connection force was found to be below specification.The reported event could be confirmed as reported; the root cause is traced to manufacturing.The device history record for lot 0004289133 was reviewed and the product was produced according to product specifications.All information reasonably known as of 13 nov 2024 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by sun med holdings llc.Represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to sun med holdings llc.Sun med holdings llc.Has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the sun med holdings complaint database and identified as complaint (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that an sun med holdings llc.Product is defective or caused serious injury.
Event or Problem Description
Sunmed holdings llc.Received a single report that referenced three different incidences, which were associated with separate units, involving three different patients.This is the first of three reports.Refer to 2028807-2024-00047 for the second report.Refer to 2028807-2024-00048 for the third report.It was reported, the clear piece came apart during the procedure; there was no reported injury.

• Brand Name: FLEX EXTENDERS
• Common Device Name: FLEX EXTENDERS 5.2
• Manufacturer (Section D): WESTMED LLC; 5580 s nogales highway; tuscon AZ 85706
• Manufacturer (Section G): WESTMED LLC; 5580 s nogales highway; tuscon AZ 85706
• Manufacturer Contact: racheal cooper ; 2710 north ridge dr nw; ste a; grand rapids, MI 49544 ; 2054826767
• MDR Report Key: 20268378
• Report Number: 2028807-2024-00035
• Device Sequence Number: 3365571
• Product Code: CAI
• UDI-Device Identifier: 10709078008402
• UDI-Public: (01)10709078008402(10)0004289133(11)240708(17)290708
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/13/2024

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: 7-5132
• Device Lot Number: 0004289133
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/22/2024
• Supplement Date Received by Manufacturer: 10/14/2024
• Initial Report FDA Received Date: 09/20/2024
• Supplement Report FDA Received Date: 11/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/08/2024
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown