MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-09-22 for SURETAC RAPID DELIVERY SYSTEM WITHOUT GLENOID GUID 720918 manufactured by Smith & Nephew Inc., Endoscopy Div..
[36998892]
Only the drill and fixator were returned for evaluation. Evaluation of the drill showed the drill is bent and bowed. The drill handle arbor is cracked and compressed. The condition of the drill is consistent with being improperly chucked. It appears that the trocar tip was getting damaged during the laser process. New fixturing was implemented in (b)(6) 2004. No conclusion could be made for the reported device failures.
Patient Sequence No: 1, Text Type: N, H10
[36998893]
During a slap lesion repair the surgeon experienced four issues with this system. Chuck from pneumatic drill stripped head od drill bit; the tolerances in diameter between guidewire and drill bit are too tight; failed to remove drill off guidewire; drill tip not aggressive or sharp enough in hard bone; impactor is too flexible 0 requires stiffer shaft for 18 degree suretac. The surgeon was able to complete the drilling with a suretac ii drill bit and place the suretac iii implant with the old instrumentation. A delay of 45 minutes resulted and the patient's glenoid surface was damaged. No other information is available at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1219602-2004-00088 |
| MDR Report Key | 5319358 |
| Date Received | 2004-09-22 |
| Date of Report | 2004-09-22 |
| Date of Event | 2004-07-29 |
| Date Facility Aware | 2004-07-29 |
| Report Date | 2004-09-22 |
| Date Mfgr Received | 2004-08-04 |
| Date Added to Maude | 2015-12-22 |
| 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 | DONNA LANTEIGNE |
| Manufacturer Street | 150 MINUTEMAN RD |
| Manufacturer City | ANDOVER MA 01810 |
| Manufacturer Country | US |
| Manufacturer Postal | 01810 |
| Manufacturer Phone | 9787491576 |
| Manufacturer G1 | SMITH & NEPHEW INC., ENDOSCOPY DIV. |
| Manufacturer Street | 130 FORBES BLVD. |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 02048 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | SURETAC RAPID DELIVERY SYSTEM WITHOUT GLENOID GUID |
| Generic Name | SURETAC RAPID DELIVERY S |
| Product Code | MOU |
| Date Received | 2004-09-22 |
| Returned To Mfg | 2004-09-03 |
| Model Number | 720918 |
| Catalog Number | 720918 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | NA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITH & NEPHEW INC., ENDOSCOPY DIV. |
| Manufacturer Address | ANDOVER MA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2004-09-22 |