MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. ZIM TRAC TRACTION SPLINT X SML; DELUXE ZIM-TRAC CONV TRACTION SPLINT, X-SMALL

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pressure Sores (2326)

Event Type  Injury  

Manufacturer Narrative

The device history record (dhr) review could not be performed.The trace lot number was not reported and is unknown.The device is a purchased finished goods product (fgp) manufactured by remington products doing business as (dba) sroufe medical.Remington products maintains manufacturing control for this device.No product was returned for evaluation.The review of the complaints and non-conformances for the past twelve months discovered no reported issues for this product and this reported event.The customers reported event is that the patient developed bed sores after using the device.With just the available information it is not possible to confirm the event or ascertain a root cause.As reported in the clinical follow up (cfu) from the customer, the development of bedsores occurred after about 1 to 2 days after surgery and placement in the splint.It was noted that bandage or wrapping around the leg to prevent bedsores was not mentioned, but towels, cushion and padding were added after the fact to protect the bedsore.Skin care static positioning in traction can cause pressure that impairs capillary flow to the skin, resulting in tissue necrosis and pressure sores.Skin integrity can be maintained by: assessing skin integrity over bony prominences and any areas of the body which are covered by or attached to traction apparatus.Massaging potential pressure areas every two to four hours.Using pressure relief devices or pressure relief beds.If skin breakdown occurs, massage should be discontinued to prevent further tissue damage.The adhesive straps used in skin traction heighten the risks to the skin and should be selected, applied, and monitored very carefully.¿ the possible cause for the reported event may be that the frequency for massaging or providing pressure relief was not adequate for this patient¿s condition.No recommended actions at this time; severity and frequency do not warrant further actions.Issue is trended by quality reports.

Event Description

It was reported that the customer allegedly developed bed sores after using the zimmer traction splint for 1-2 days.

• Brand Name: ZIM TRAC TRACTION SPLINT X SML
• Type of Device: DELUXE ZIM-TRAC CONV TRACTION SPLINT, X-SMALL
• 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: jennifer hutchison ; 200 west ohio avenue; dover, OH 44622 ; 3303438801
• MDR Report Key: 5485568
• MDR Text Key: 39858145
• Report Number: 0001526350-2016-00027
• Device Sequence Number: 1
• Product Code: HSP
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/15/2016

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?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00275301000
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/15/2016
• Initial Date FDA Received: 03/08/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1