MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2019-12-23 for SYMMETRY CLASSIC PLUS 36-2025 manufactured by Symmetry Surgical Inc.
[188933247]
There has been a total of (b)(6) sold of this product code since 2013 with 3 other complaints recorded for similar occurrences. This equates to a (b)(6) complaint rate which is categorized as low. The product has not been received for evaluation. A follow-up report will be submitted once new information is acquired.
Patient Sequence No: 1, Text Type: N, H10
[188933248]
At the conclusion of the procedure, when placing the sternal wires, the "insert" from the sternal wire needle driver became dislodged from the instrument and was retained in the patient's chest. Per x-ray, the patient underwent an additional surgery to partially reopen the chest wall to revolve the piece. As a result, the patient remained in the hospital for two additional inpatient admission days.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007208013-2019-00039 |
| MDR Report Key | 9511537 |
| Report Source | USER FACILITY |
| Date Received | 2019-12-23 |
| Date of Report | 2019-12-23 |
| Date of Event | 2019-08-01 |
| Date Mfgr Received | 2020-01-02 |
| Date Added to Maude | 2019-12-23 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | BRANDI MEATH |
| Manufacturer Street | 3034 OWEN DRIVE |
| Manufacturer City | ANTIOCH TN 37013 |
| Manufacturer Country | US |
| Manufacturer Postal | 37013 |
| Manufacturer Phone | 6159645290 |
| Manufacturer G1 | SYMMETRY SURGICAL INC |
| Manufacturer Street | 3034 OWEN DRIVE |
| Manufacturer City | ANTIOCH TN 37013 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 37013 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SYMMETRY CLASSIC PLUS |
| Generic Name | STERNAL NEEDLE HOLDER |
| Product Code | HXK |
| Date Received | 2019-12-23 |
| Returned To Mfg | 2020-01-02 |
| Catalog Number | 36-2025 |
| Lot Number | 31018167 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYMMETRY SURGICAL INC |
| Manufacturer Address | 3034 OWEN DRIVE ANTIOCH TN 37013 US 37013 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-12-23 |