MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,01,06,08 report with the FDA on 2010-08-27 for ULTRAFIX MICROMITE SUTURE ANCHOR 10301 manufactured by Conmed Linvatec.
[1589085]
It was reported that during a scapholunate ligament repair of the wrist on (b)(6) 2009, two anchors were successfully implanted with no noted discrepancies. However, approx two months post-operatively, the pt required a revision surgery to remove the two anchors due to migration out of the bone into the soft tissue. When the anchors were removed, the surgeon elected not to replace them due to the pt's diagnosis of osteoarthritis and disease progression. The date of the second surgery was not reported. The device used to implant the anchors include: inserter gun, ultrafix micromite, cat # 10299, lot # 129553. Drill guide, micromite, 1. 8mm, cat # 10298, lot # 94234. These devices remained in circulation and were used in subsequent surgeries with no discrepancies until requested.
Patient Sequence No: 1, Text Type: D, B5
[8693682]
The removed anchors were discarded by the user facility after the second surgery, therefore, an eval was unable to be conducted. A two (2) year review of complaint history shows no similar reports for this lot (18209) and/or product (10301). The inserter for this device was returned for eval. (note: due to continued use for additional surgeries, the condition of this unit may not be indicative of the unit when used for the initial surgery). The eval noted the internal compression collet had one spline slightly bent out of position. The instructions for use state the following: contraindications: pathological conditions of bone, such as cystic changes or severe osteopenia or comminuted bone surface which would adversely affect the ultrafix micromite suture anchor. Pathological conditions in the soft tissue to be repaired or reconstructed which would adversely affect suture fixation. Physical conditions that would eliminate, or tend to eliminate, adequate implant support or retard healing. Conditions which tend to limit the pt's ability or willingness to restrict activities or follow directions during the healing period. Warning: any decision to remove the device should take into consideration the potential risk to the pt of a second surgical procedure. Implant removal should be followed by adequate postoperative management.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1017294-2010-00091 |
| MDR Report Key | 1825943 |
| Report Source | 00,01,06,08 |
| Date Received | 2010-08-27 |
| Date of Report | 2010-08-23 |
| Date Mfgr Received | 2010-08-23 |
| Device Manufacturer Date | 2001-07-01 |
| Date Added to Maude | 2011-04-27 |
| 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 | BRENDA JOHNSON |
| Manufacturer Street | 11311 CONCEPT BLVD. |
| Manufacturer City | LARGO FL 33773 |
| Manufacturer Country | US |
| Manufacturer Postal | 33773 |
| Manufacturer Phone | 7273995515 |
| 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 | ULTRAFIX MICROMITE SUTURE ANCHOR |
| Generic Name | LM ANCHOR |
| Product Code | NOV |
| Date Received | 2010-08-27 |
| Catalog Number | 10301 |
| Lot Number | 18209 |
| Device Expiration Date | 2006-07-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CONMED LINVATEC |
| Manufacturer Address | LARGO FL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2010-08-27 |