MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2016-03-08 for ZIM TRAC TRACTION SPLINT X SML N/A 00275301000 manufactured by Zimmer Surgical, Inc..
[39858145]
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.
Patient Sequence No: 1, Text Type: N, H10
[39858146]
It was reported that the customer allegedly developed bed sores after using the zimmer traction splint for 1-2 days.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001526350-2016-00027 |
| MDR Report Key | 5485568 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2016-03-08 |
| Date of Report | 2016-02-15 |
| Date Mfgr Received | 2016-02-15 |
| Date Added to Maude | 2016-03-08 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JENNIFER HUTCHISON |
| Manufacturer Street | 200 WEST OHIO AVENUE |
| Manufacturer City | DOVER OH 44622 |
| Manufacturer Country | US |
| Manufacturer Postal | 44622 |
| Manufacturer Phone | 3303438801 |
| Manufacturer G1 | ZIMMER SURGICAL, INC. |
| Manufacturer Street | 200 WEST OHIO AVENUE |
| Manufacturer City | DOVER OH 44622 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 44622 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ZIM TRAC TRACTION SPLINT X SML |
| Generic Name | DELUXE ZIM-TRAC CONV TRACTION SPLINT, X-SMALL |
| Product Code | HSP |
| Date Received | 2016-03-08 |
| Model Number | N/A |
| Catalog Number | 00275301000 |
| Lot Number | UNK |
| ID Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZIMMER SURGICAL, INC. |
| Manufacturer Address | 200 WEST OHIO AVENUE DOVER OH 44622 US 44622 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-03-08 |