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 2019-04-23 for ROD CUTTER 388.720 manufactured by Oberdorf Synthes Produktions Gmbh.
[142779097]
Complainant part is not expected to be returned for manufacturer review/investigation. (b)(4). Without a lot number the device history records review could not be completed. Product was not returned. Based on the information available, it has been determined that no corrective and/or preventative action is proposed. This complaint will be accounted for and monitored via post market surveillance activities. If additional information is made available, the investigation will be updated as applicable. Device was used for treatment, not diagnosis. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
[142779098]
Device report from synthes reports an event in argentina as follows: it was reported that a patient underwent surgery on (b)(6) 2019 to correct scoliosis. During the surgery, the front grips of the bolt cutter were extremely worn and open so that it was impossible to perform the gripping maneuvers. The cut bar was in bad condition and was not suitable for cutting cobalt chrome bars. There was bending of the cutting edge of the bars which made it impossible to cut with the in-situ bars. When trying to make the final adjustment of the system, the anti-torque of the bolt cutter did not work. The shear did not cut properly, that's why the inners had to be removed to cut the bar outside. When trying to make the final adjustment, due to the wear of the unknown screwdriver it was impossible to reach the end of the adjustment because it rounded the nuts of the system. The final adjustment was attempted, however eight (8) unknown consecutive nuts were rounded (inners were nicked). Procedure was not successfully completed. There was a surgical delay of one (1) hour. Patient outcome is reported as not being able to fully correct the deformity and not able to make the adjustment. This report is for one (1) bolt cutter. This is report 1 of 1 for complaint (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030965-2019-63065 |
| MDR Report Key | 8540453 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-04-23 |
| Date of Report | 2019-03-27 |
| Date of Event | 2019-03-22 |
| Date Mfgr Received | 2019-06-23 |
| Device Manufacturer Date | 2018-05-15 |
| Date Added to Maude | 2019-04-23 |
| 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 | KARA DITTY-BOVARD |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 6103142063 |
| Manufacturer G1 | SYNTHES TUTTLINGEN |
| Manufacturer Street | UNTER HASSLEN 5 |
| Manufacturer City | TUTTLINGEN 78532 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 78532 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ROD CUTTER |
| Generic Name | CUTTER,WIRE |
| Product Code | HXZ |
| Date Received | 2019-04-23 |
| Returned To Mfg | 2019-05-03 |
| Catalog Number | 388.720 |
| Lot Number | T165145 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OBERDORF SYNTHES PRODUKTIONS GMBH |
| Manufacturer Address | EIMATTSTRASSE 3 OBERDORF 4436 SZ 4436 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-04-23 |