MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,07 report with the FDA on 2007-12-18 for POWERPRO STERILE TRANSFER BATTERY CASE PRO3110 manufactured by Conmed Linvatec.
[747823]
The customer reported that during use of this battery case in a total arthroplasty surgery, the rails broke. The user reported notable vibration of the handpiece in use. This event resulted in the battery case falling off of the handpiece and pieces of the rail falling into the surgical site. The customer reported difficulty removing the rail fragments from the surgical site but this did not result in injury to the patient.
Patient Sequence No: 1, Text Type: D, B5
[7902825]
Investigation results: conmed linvatec is unable to confirm this reported problem because the device is not being returned for evaluation. The instructions for use contain the following warning: inspect the sterile transfer battery case for any damage, such as: cracks in the case, or damaged, broken, or worn o-rings, latch and/or hinge. If damage is found, do not use. Sterility may be compromised and patient infection may occur. A corrective action is in process to address this failure mode. Conmed linvatec will continue to monitor this device for failures.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1017294-2007-00848 |
| MDR Report Key | 972777 |
| Report Source | 01,05,07 |
| Date Received | 2007-12-18 |
| Date of Report | 2007-11-23 |
| Date of Event | 2007-11-20 |
| Date Mfgr Received | 2007-11-23 |
| Date Added to Maude | 2008-04-18 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | BEVERLY SCHANER |
| Manufacturer Street | 11311 CONCEPT BLVD. |
| Manufacturer City | LARGO FL 33773 |
| Manufacturer Country | US |
| Manufacturer Postal | 33773 |
| Manufacturer Phone | 7273995169 |
| Manufacturer G1 | CONMED LINVATEC |
| Manufacturer Street | 11311 CONCEPT BLVD. |
| Manufacturer City | LARGO FL 33773 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 33773 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | POWERPRO STERILE TRANSFER BATTERY CASE |
| Generic Name | BATTERY CASE |
| Product Code | FCO |
| Date Received | 2007-12-18 |
| Catalog Number | PRO3110 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 975424 |
| Manufacturer | CONMED LINVATEC |
| Manufacturer Address | LARGO FL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-12-18 |