MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. SPLINT WRIST COCKUP UNIV L; ORTHOSIS, LIMB BRACE

Model Number N/A

Device Problem Material Integrity Problem (2978)

Patient Problems Rash (2033); Skin Irritation (2076)

Event Type  Injury  

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).The receiving / inspection record (rir) for the universal left cock-up wrist splint, part number 00176900300 and lot number 46165, review noted no related non-conformances, requests for deviation (rfd), change notices (cn), or any other issues with manufacturing.The dhr review found no issues with the device and all verifications, inspections, and tests were successfully completed.On 05 dec 2016, it was reported from (b)(6) care that a universal left cock-up wrist splint caused the patient to break out in dermatitis while wearing the device.On 02 feb 2017, the foam material composition was investigated by the supplier based on a representative sample of the device from the reported manufacturing lot.The actual returned complaint product was not forwarded to the supplier for testing.The attached supplier survey and third party lab testing reveal that the raw materials used on the inside of the splint which touches the skin did not contain any chemicals that would cause irritation to the skin such as latex, formaldehyde, or dehp.The material was also confirmed to be reach compliant.The results of the returned product investigation can, therefore, not confirm the reported event.The supplier was not able to identify any allergens in the raw materials of the related lot nor identify any other issues that would cause an irritation for the user.The root cause of the reported event cannot be specifically determined with the provided information.The investigation was based on the information that was provided initially and any information that was obtained throughout the follow-up process.

Event Description

It was reported that patient got contact dermatitis from wearing a wrist brace.Patient went back to the physician who recommended a cream that cleared up the rash approximately 3-5 days later.Instead of wearing the brace, he in turn had to get a cast put on.No additional patient consequences have been reported as a result of this malfunction.

Manufacturer Narrative

This follow-up report is being filed to relay corrected information.

• Brand Name: SPLINT WRIST COCKUP UNIV L
• Type of Device: ORTHOSIS, LIMB BRACE
• Manufacturer (Section D): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• Manufacturer (Section G): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• Manufacturer Contact: christina arnt ; 56 e. bell drive; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6872040
• MDR Text Key: 86456897
• Report Number: 0001526350-2017-00688
• Device Sequence Number: 1
• Product Code: IQI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 09/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00176900300
• Device Lot Number: 46165
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/18/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/26/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention