MAUDE Adverse Event Report: DJO, LLC EXOS SHORT THUMB SPICA II (STSII), HAND BASED, BLK, L, L; ORTHOSIS, LIMB BRACE

Model Number 212-61-1111

Device Problem Crack (1135)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 10/01/2018

Event Type  Injury  

Manufacturer Narrative

Upon completion of an audit of the dj orthopedics (b)(4), fda issued a finding on 13 december 2018 that "procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have not been adequately established." this report is being submitted as part of djo's efforts to address this finding.Device evaluated by mfr: no device was returned for evaluation.If the device is received, a follow-up report will be submitted upon completion of product evaluation.No lot number was provided, so a device record review could not be performed.Complaint data for similar products and issues going back 9 months has been reviewed.The trend indicates that reported customer complaints are within control.

Event Description

It was reported that the patient was playing volleyball when he was injured while wearing the brace, requiring surgery to the thumb.The brace reportedly cracked during the incident.Further information was requested, but not provided.

• Brand Name: EXOS SHORT THUMB SPICA II (STSII), HAND BASED, BLK, L, L
• Type of Device: ORTHOSIS, LIMB BRACE
• Manufacturer (Section D): DJO, LLC; 1430 decision street; vista CA 92081 9663
• Manufacturer (Section G): DJ ORTHOPEDICS DE MEXICO, S.A. DE C.V.; carretera libre tijuana tecate; 20230 submetropoli el florido; tijuana, b.c. 22244, ; MX
• Manufacturer Contact: brian becker ; 2900 lake vista drive; lewisville, TX 75067
• MDR Report Key: 8734885
• MDR Text Key: 149204974
• Report Number: 9616086-2019-00040
• Device Sequence Number: 1
• Product Code: IQI
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial
• Report Date: 06/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 212-61-1111
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/01/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention