MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-30 for PHS393039010A manufactured by Medline Industries Inc..
[143699833]
It was reported that during a knee scope procedure, the surgical blade that was used for incision came off its handle, falling inside the patient's knee cavity. It was added that while retrieving the blade, the blade broke into four pieces. Reportedly, the two large pieces of the broken blade were immediately retrieved and the third piece was retrieved with aid of c-arm (imaging device). The blade was reassembled and it was discovered that the tip (2mm) of blade was still missing. A plain film was obtained in anterior/posterior and lateral views and this was read by a radiologist, who confirmed that there was no visible remnant of blade retained in patient. Per report, it is believed that the missing piece had been flushed out with arthroscopic irrigation. It is unknown if any issue was noted with the surgical blade during inspection prior to use and whether any excessive force was applied to or against the blade during use. The patient was reportedly discharged the same day and recovered appropriately. General anesthesia was used and there was no report of any adverse patient consequence and no effect on the patient's stability as a result of the incident. No impact to the patient, the staff, the procedure, or the total length of the procedure was reported. Due to the reported event and medical intervention required to retrieve the broken pieces of the surgical blade, this medwatch is being filed. The sample has been discarded and is not available to be returned for evaluation. A definitive root cause could not be determined at this time. No additional information is available. If additional information becomes available, a supplemental medwatch will be filed.
Patient Sequence No: 1, Text Type: N, H10
[143699834]
It was reported that the surgical blade broke into four pieces.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423395-2019-00012 |
| MDR Report Key | 8565196 |
| Date Received | 2019-04-30 |
| Date of Report | 2019-04-30 |
| Date of Event | 2019-03-21 |
| Date Mfgr Received | 2019-04-04 |
| Date Added to Maude | 2019-04-30 |
| 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 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | BERMON PUNZALAN |
| Manufacturer Street | THREE LAKES DRIVE |
| Manufacturer City | NORTHFIELD IL 60093 |
| Manufacturer Country | US |
| Manufacturer Postal | 60093 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Generic Name | SURGICAL BLADE FROM CUSTOM ARTHROSCOPY TRAY |
| Product Code | OII |
| Date Received | 2019-04-30 |
| Catalog Number | PHS393039010A |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES INC. |
| Manufacturer Address | THREE LAKES DRIVE NORTHFIELD IL 60093 US 60093 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-04-30 |