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 2018-06-25 for SYPERT BONE RONGEUR 8/360MM FG052R manufactured by Aesculap Ag.
[112453086]
(b)(4). Manufacturing site evaluation: evaluation on-going.
Patient Sequence No: 1, Text Type: N, H10
[112453087]
Country of complaint: (b)(6). In order to create space for the blood vessels and nerves between the first rib and clavicula the first rib had to be removed. First step is to cut the first rib (a piece) with a bone cutting forceps, second step is to make the sharp edges as a result of cutting less sharp in to prevent stabbing through the pleara viscerale which can cause a pneumothorax, or stabbing through the blood vessels or nerves. For this second step the fg052r is supposed to bite small bits from the sharp edges without using to much pressure because to much pressure can cause the rib to shatter or splinter which is exactly what happened. A splinter punctured the pleura viscerale. To prevent a pneumothorax after surgery the or team placed a small thoraxdrain. The fg052r was delivered on 8 may and used for the first time. The initial feedback on 8 may (no complaint) only stated the fg052r being blunt. The complaint was received (b)(6) may. Unfortunately in between this dates the fg052r was being cut by our instrument repair department. The surgeon who submitted the complaint tried the same fg052r after it was cut with the same result. It does not cut without a lot of pressure which only leaves the question i think if the double hinge creates enough leverage.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610612-2018-00254 |
| MDR Report Key | 7635751 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-06-25 |
| Date of Report | 2018-07-02 |
| Date of Event | 2017-05-08 |
| Date Facility Aware | 2018-06-11 |
| Date Mfgr Received | 2018-05-28 |
| Device Manufacturer Date | 2018-01-31 |
| Date Added to Maude | 2018-06-25 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. NICOLE BROYLES |
| Manufacturer Street | 615 LAMBERT POINTE DRIVE |
| Manufacturer City | HAZELWOOD MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer G1 | AESCULAP AG |
| Manufacturer Street | PO BOX 40 |
| Manufacturer City | TUTTLINGEN, 78501 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 78501 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SYPERT BONE RONGEUR 8/360MM |
| Generic Name | BONE RONGEURS AND BONE CUTTING FORC |
| Product Code | HTX |
| Date Received | 2018-06-25 |
| Returned To Mfg | 2018-06-12 |
| Model Number | FG052R |
| Catalog Number | FG052R |
| Lot Number | 4509212949 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 5 MO |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AESCULAP AG |
| Manufacturer Address | PO BOX 40 TUTTLINGEN, 78501 GM 78501 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-06-25 |