MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-09-05 for HNM MEDICAL KERRISON HNM-1-57-0554 157-0554 manufactured by Hnm Stainless, Llc Dba Hnm Medical.
[119536782]
This event was not initially reported as there was no clinical complications. This customer complaint was re-evaluated in (b)(6) 2018 to see if the event were to reoccur could a serious injury occur. Since a malfunction of this type may result in either complications or a prolonged procedure, a decision was made to file this as an mdr. Investigation conclusion: this item is a delicate product with a thin footplate which is specifically designed for small bones in the cervical area. One of the important aspects of using this product is not to twist or pry the instrument while cutting the bone. Moreover product cannot be used on larger bones. Product was used unintendedly or the product fell on the floor or on steel table and the thin foot place got all the force of impact in that small area and as a result it cracked. The product is very durable for normal intended use against any pressure, stress and is very hard and difficult to break. But it is vulnerable to shock though - impact against a hard object. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[119536783]
On (b)(6) 2016, hnm's (b)(6) representative reported a broken kerrison rongeur - catalog # 1-57-0554. Item was purchased on (b)(6) 2014. Event description: the tip broke off in the spinal canal during surgery. No clinical complications. No additional information available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005031118-2018-00003 |
| MDR Report Key | 7847000 |
| Date Received | 2018-09-05 |
| Date of Report | 2018-09-04 |
| Date of Event | 2016-11-03 |
| Date Mfgr Received | 2017-01-23 |
| Date Added to Maude | 2018-09-05 |
| 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. DAN SRAGOVICZ |
| Manufacturer Street | 20855 NE 16TH AVE SUITE C15 |
| Manufacturer City | MIAMI FL 33179 |
| Manufacturer Country | US |
| Manufacturer Postal | 33179 |
| Manufacturer G1 | HNM STAINLESS, LLC DBA HNM MEDICAL |
| Manufacturer Street | 20855 NE 16TH AVE SUITE C15 |
| Manufacturer City | MIAMI FL 33179 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 33179 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | HNM MEDICAL KERRISON |
| Generic Name | SPURLING KERRISON RONGEUR |
| Product Code | HTX |
| Date Received | 2018-09-05 |
| Returned To Mfg | 2016-12-19 |
| Model Number | HNM-1-57-0554 |
| Catalog Number | 157-0554 |
| Lot Number | C3/13 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HNM STAINLESS, LLC DBA HNM MEDICAL |
| Manufacturer Address | 20855 NE 16TH AVE SUITE C15 MIAMI FL 33179 US 33179 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-09-05 |