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U.S. Department of Health and Human Services

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

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DJO, LLC EXOS SHORT THUMB SPICA II (STSII), HAND BASED, BLK, L, L ORTHOSIS, LIMB BRACE Back to Search Results
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.

 
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Brand NameEXOS SHORT THUMB SPICA II (STSII), HAND BASED, BLK, L, L
Type of DeviceORTHOSIS, 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 Key8734885
MDR Text Key149204974
Report Number9616086-2019-00040
Device Sequence Number1
Product Code IQI
Combination Product (Y/N)N
PMA/PMN NumberEXEMPT
Number of Events Reported1
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 Received06/26/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number212-61-1111
Was Device Available For Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/01/2018
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 Unkown

Patient TREATMENT DATA
Date Received: 06/26/2019 Patient Sequence Number: 1
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