MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2006-09-22 for CODMAN SKULL TONG 66-1025 manufactured by Codman & Shurtleff, Inc..
[499806]
Rep reports that the product fractured the patients skull.
Patient Sequence No: 1, Text Type: D, B5
[7834249]
Upon completion of the investigation it was noted that this complaint was non-verifiable. Evaluation of the three skull tongs received indicated that one of the tongs was assembled correctly. This tong has a spring-loaded point (screw) and a solid point (screw) in place. The other two tongs have two solid point screws (1 tong) and 2 spring loaded screws (1 tong). It appears that the instruments have been re-assembled incorrectly. Incorrect assembly may contribute to poor instrument function. These instruments are inspected during the manufacturing process, incorrect assembly would have been detected during inspection. There were no metallurgic defects such as corrosion on the metal surfaces. All screws demonstrated well formed threads and were fully functional. This complaint is associated with improper assembly in the clinical setting and is not attributed to manufacturing processes. Corrective action is not deemed necessary based on the analysis results. Trends will be monitored for this and/or smaller complaints. At the present time this complaint is considered closed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1226348-2006-00254 |
| MDR Report Key | 763944 |
| Report Source | 07 |
| Date Received | 2006-09-22 |
| Date Mfgr Received | 2006-08-25 |
| Date Added to Maude | 2006-09-26 |
| 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 | 0 |
| Manufacturer Contact | MATTHEW KING |
| Manufacturer Street | 325 PARAMOUNT DRIVE |
| Manufacturer City | RAYNHAM MA 02767 |
| Manufacturer Country | US |
| Manufacturer Postal | 02767 |
| Manufacturer Phone | 5088283106 |
| Manufacturer G1 | CODMAN & SHURTLEFF, INC |
| Manufacturer Street | 325 PARAMOUNT DRIVE |
| Manufacturer City | RAYNHAM MA 02767 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 02767 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CODMAN SKULL TONG |
| Generic Name | VARIOUS SKULL TONGS FOR TRACTION |
| Product Code | HAX |
| Date Received | 2006-09-22 |
| Returned To Mfg | 2006-09-05 |
| Model Number | NA |
| Catalog Number | 66-1025 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 751820 |
| Manufacturer | CODMAN & SHURTLEFF, INC. |
| Manufacturer Address | 325 PARAMOUNT DRIVE RAYNHAM MA 02767 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2006-09-22 |