MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES S/M ALEXIS ORTHO PROTECTOR; KGW

Model Number	7
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Injury (2348)
Date of Event	03/07/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product is being returned for evaluation, but a lot # is provided.A device history report is to be reviewed by engineering.A final report will be sent once the results have been analyzed.
Event or Problem Description
Total shoulder replacement - the surgeon used the alexis ortho for the first time on this patient.He only kept the product in place for approximately 5 minutes of the surgery.It slipped out on one occasion and he repositioned it in place beneath the deltoid and the pec major.He found it to be obstructing his view, so he decided not to continue using it on this occasion and product remained out for the majority of the procedure.When [the territory manager] met the surgeon he mentioned that a coracoid process fracture had occurred to that patient.Type of intervention - removed alexis ortho and not used for remainder of surgery.Patient status - "the coracoid process fracture was discovered and treated post surgery.".

• Brand Name: S/M ALEXIS ORTHO PROTECTOR
• Common Device Name: KGW
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 6494211
• Report Number: 2027111-2017-01649
• Device Sequence Number: 13817590
• Product Code: KGW
• UDI-Device Identifier: 00607915123185
• UDI-Public: (01)00607915123185(17)190708(30)01(10)1273901
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: 7
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/14/2017

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 Expiration Date: 07/08/2019
• Device Model Number: 7
• Device Catalogue Number: 7
• Device Lot Number: 1273901
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/21/2017
• Initial Report FDA Received Date: 04/14/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other