MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2018-12-18 for IPS 60-500-01-09 manufactured by Kls Manufacturing.
[130784928]
An investigation was performed on the basis of complaint statistics as no device was returned for evaluation. The complaint percentage was calculated, and it is determined that the complaint percentage falls within the design risk limits. During the investigation the product lot number identified was reviewed in the device history records. The dhr review showed no discrepancies or anomalies. The failure root cause cannot be determined due to no device being returned. If further information is obtained that might add value to the contents of the investigation report, an additional follow-up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[130784929]
It was reported that a splint deformed and cracked during the sterilization process. Discovered upon opening in the sterile field. A delay of 30 minutes was observed to get back-up product to complete the procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3014483751-2018-00001 |
| MDR Report Key | 8176152 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-12-18 |
| Date of Report | 2018-11-28 |
| Date of Event | 2018-11-28 |
| Date Facility Aware | 2018-11-28 |
| Report Date | 2018-11-28 |
| Date Reported to Mfgr | 2018-11-28 |
| Date Mfgr Received | 2018-11-28 |
| Date Added to Maude | 2018-12-18 |
| 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 | MR. TOM JOHNSTON |
| Manufacturer Street | 11228 ST JOHNS INDUSTRI PKWY S |
| Manufacturer City | JACKSONVILLE FL 32246 |
| Manufacturer Country | US |
| Manufacturer Postal | 32246 |
| Manufacturer Phone | 9046410421 |
| Manufacturer G1 | KLS MANUFACTURING |
| Manufacturer Street | 11228 ST JOHNS INDUSTRI PKWY S |
| Manufacturer City | JACKSONVILLE FL 32246 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 32246 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IPS |
| Generic Name | SPLINT |
| Product Code | KMY |
| Date Received | 2018-12-18 |
| Model Number | 60-500-01-09 |
| Lot Number | 8000002693 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KLS MANUFACTURING |
| Manufacturer Address | 11228 ST JOHNS INDUSTRIAL PKWY JACKSONVILLE 32246 US 32246 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-12-18 |