MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2008-10-03 for KINSA SUTURE ANCHOR SYSTEM 72200239 manufactured by Smith & Nephew Inc., Endoscopy Div..
[948833]
During a labral and bankart repair, while hammering the anchors down, the top peeled off of the anchor; it seemed to shatter. The surgeon used the awl and did not drill. This occurred with two anchors; the patient had hard bone. Anchors remain in patient, and the surgeon was fine with this as he felt it would still hold, and there will not be a problem. No delay and no patient injury or complications resulted.
Patient Sequence No: 1, Text Type: D, B5
[8260583]
No product is being returned for evaluation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1219602-2008-00223 |
| MDR Report Key | 1188119 |
| Report Source | 06,07 |
| Date Received | 2008-10-03 |
| Date of Report | 2008-09-08 |
| Date of Event | 2008-09-08 |
| Date Facility Aware | 2008-09-08 |
| Report Date | 2008-09-30 |
| Date Mfgr Received | 2008-09-08 |
| Date Added to Maude | 2009-03-26 |
| 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 | 3 |
| Manufacturer Contact | JASON BILOBRAM |
| Manufacturer Street | 150 MINUTEMAN ROAD |
| Manufacturer City | ANDOVER MA 01810 |
| Manufacturer Country | US |
| Manufacturer Postal | 01810 |
| Manufacturer Phone | 9787491630 |
| 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 | 3 |
| Brand Name | KINSA SUTURE ANCHOR SYSTEM |
| Generic Name | KINSA |
| Product Code | KGS |
| Date Received | 2008-10-03 |
| Model Number | 72200239 |
| Catalog Number | 72200239 |
| Lot Number | UNKNOWN |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITH & NEPHEW INC., ENDOSCOPY DIV. |
| Manufacturer Address | MANSFIELD MA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-10-03 |