MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-20 for SYMMETRY SHARP KERRISON 53-1676 manufactured by Symmetry Surgical, Inc.
[128199310]
Instrument was purchased (b)(6) 2018 on order # (b)(6). Initial inspection of the instrument showed that the bottom locking mechanism was broken. The lot number indicates that this is the new design for the sharp kerrison handles. Material and hardness were in conformance to products specs. The sharp kerrison consists of two devices in one to include the reusable handle (device identified in report) and tips (single use and reusable versions available) assembled to complete the usable device. The detachable tips were specifically designed as removable to support use and removal once dull which is common for devices with a cutting feature. Unfortunately, the tips were not returned with the handles to assess this condition. (ref complaint# (b)(4)) through testing, symmetry could identify that when additional forces are applied to the locking mechanism of the handle by excessively squeezing and twisting the handle, during the use of a dull blade or while cutting a large or dense bone, the bottom lock will yield. The results of the testing did not break the locking mechanism; however, it did show stress in the same location. This type of use is not recommended as it is defined as a warning in the ifu. Based on the results of the testing, symmetry chose to further improve the safety of the product by increasing the thickness of the bottom locking mechanism that experiences all the stress. This will be a running change to the device design. The same cautions in the ifu apply to the new design as well. This report can be seen as the final report. If additional information is obtained that alleges any additional patient involvement or the need for any corrective actions a follow-up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[128199311]
The customer alleged that during the third use, the bottom locking mechanism broke off and the tip could not be reattached.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007208013-2018-00027 |
| MDR Report Key | 8092561 |
| Date Received | 2018-11-20 |
| Date of Report | 2018-11-20 |
| Date of Event | 2018-10-23 |
| Date Mfgr Received | 2018-10-23 |
| Date Added to Maude | 2018-11-20 |
| 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 | BRANDI MEATH |
| Manufacturer Street | 3034 OWEN DR |
| Manufacturer City | ANTIOCH, |
| 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 | 0 |
| Brand Name | SYMMETRY SHARP KERRISON |
| Generic Name | KERRISON RONGEUR |
| Product Code | HAE |
| Date Received | 2018-11-20 |
| Returned To Mfg | 2018-11-08 |
| Catalog Number | 53-1676 |
| Lot Number | 1500495- |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2018-11-20 |