MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-12-01 for TMAX SHOULDER TABLE TBD 7210551 manufactured by Smith & Nephew, Inc..
[32489841]
The device has not been returned. Due to the device not being returned, we are unable to determine what may have caused the user to experience the reported incident. In the event the sample is returned for evaluation the complaint will be reopened for additional investigation. No further investigation is necessary at this time. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[32489842]
Reportedly, the gold ball that is connected to the metal rod which controls the head height on the tmax shoulder table came loose during surgery. The head was unstable during the procedure and the surgeon or anaesthetist had to hold the head secure during the operation. It is reported that the patient's head was not in the correct position during the procedure and this could have caused an injury.
Patient Sequence No: 1, Text Type: D, B5
[37455610]
One customer headset positioning system was received on 12/23/2015 and confirmed to be serial number (b)(4). The complaint reported that the device became loose and inadvertently caused instability of the patient? S head during a surgery. Upon visual inspection, no damages to the unit were found. The unit was functionally tested with the 30-lb slip test per procedure and the unit was able to perform as expected. Upon closer examination, it was determined that the thread locker used to mate, lock, and seal the ball & socket subassembly ((b)(4)) to the slide hex bar (b)(4) had failed. The investigation concludes that it is possible that an inadequate amount of thread locker was applied into the ball & socket subassembly when assembling due to operator error during the manufacturing process. This issue was previously addressed with defect awareness training. The assembly procedure was also updated to reflect proper application and amount to use. The actual date of manufacture is unknown, but this unit was manufactured by tenet medical prior to the smith & nephew acquisition. Therefore, it was manufactured prior to the awareness training. The unit will be sent to service for repairs. No further investigation is warranted at this time. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1643264-2015-00188 |
| MDR Report Key | 5257607 |
| Date Received | 2015-12-01 |
| Date of Report | 2015-11-05 |
| Date of Event | 2015-11-04 |
| Date Mfgr Received | 2016-02-03 |
| Date Added to Maude | 2015-12-01 |
| 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 | JAMES GONZALES |
| Manufacturer Street | 130 FORBES BOULEVARD |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 5123585706 |
| Manufacturer G1 | SMITH & NEPHEW, INC. |
| Manufacturer Street | 76 S. MERIDIAN AVE. |
| Manufacturer City | OKLAHOMA CITY OK 731076512 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 731076512 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TMAX SHOULDER TABLE |
| Generic Name | TABLE AND ATTACHMENTS, OPERATING-ROOM |
| Product Code | BWN |
| Date Received | 2015-12-01 |
| Returned To Mfg | 2015-12-23 |
| Model Number | TBD |
| Catalog Number | 7210551 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITH & NEPHEW, INC. |
| Manufacturer Address | 76 S. MERIDIAN AVE. OKLAHOMA CITY OK 731076512 US 731076512 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-12-01 |