MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2005-12-09 for BIORAPTOR INLINE DRILL GUIDE 72200181 manufactured by Smith & Nephew, Inc., Endoscopy Division.
[407858]
Sales representative reported that the tip of this drill guide bent and when the drill was inserted, there were shavings in the joint. Due to the way the guide bent, the bioraptor anchor itself had difficulty being inserted and wound up being left proud during insertion the sutures also became cut on the bend guide tip. Sales rep. Stated that the tip of the guide was only visually bent when put into the joint and magnified by the scope. The bend was barely noticable to the naked eye. It was confirmed that once the shavings were noted in the joint, it was immediately flushed. The sutures were cut by the bent guide was straightened by the technician. The surgeon experienced a delay of approximately 15-minutes and no patient injury resulted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1219602-2005-00137 |
| MDR Report Key | 652738 |
| Report Source | 06,07 |
| Date Received | 2005-12-09 |
| Date of Report | 2005-12-07 |
| Date of Event | 2005-11-07 |
| Date Facility Aware | 2005-11-07 |
| Report Date | 2005-12-07 |
| Date Mfgr Received | 2005-11-08 |
| Date Added to Maude | 2005-12-16 |
| 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 ROAD |
| Manufacturer City | ANDOVER MA 01810 |
| Manufacturer Country | US |
| Manufacturer Postal | 01810 |
| Manufacturer Phone | 9787491576 |
| Manufacturer G1 | SMITH & NEPHEW INC. ENDOSCOPY DIVISION |
| 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 | 3 |
| Brand Name | BIORAPTOR INLINE DRILL GUIDE |
| Generic Name | DRILL GUIDE |
| Product Code | LXI |
| Date Received | 2005-12-09 |
| Model Number | 72200181 |
| Catalog Number | 72200181 |
| Lot Number | UNK |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | UNK |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 642206 |
| Manufacturer | SMITH & NEPHEW, INC., ENDOSCOPY DIVISION |
| Manufacturer Address | * ANDOVER MA * US |
| Baseline Brand Name | BIORAPTOR INLINE DRILL GUIDE |
| Baseline Generic Name | DRILL GUIDE |
| Baseline Model No | 72200181 |
| Baseline Catalog No | 72200181 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2005-12-09 |