MAUDE Adverse Event Report: SYMMETRY SURGICAL INC SYMMETRY SURGICAL; SIDE CUTTING FORCEPS

Catalog Number 32-118

Device Problem Material Fragmentation (1261)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

The date of the incident is unknown.The return of the device is anticipated.Once we have received the device and evaluated.A follow-up report will be submitted.The delay in the fda receiving this complaint was due to a change in esignature certificates.

Event Description

When the surgeon cut the pin, the pin cutter blade broke into multiple pieces and went into the patient's right ankle.The surgeon had to do an ankle scope on the patient to retrieve the foreign bodies.Using x-ray and the scope the all of the pieces were retrieved.

Manufacturer Narrative

After multiple attempts, the device was not returned for evaluation.Based on the lot number provided in the intial report of the complaint, this device was purchased in dec 2016 and had been in use for approximately 2 years at the time that the complaint was reported.Because the device not been returned, a root cause could not be determined, therefore, this can be seen as the final report.If additional information is obtained that alleges any additinal patient involvement or the need for corrective actions a follow-up report will be submitted.

• Brand Name: SYMMETRY SURGICAL
• Type of Device: SIDE CUTTING FORCEPS
• Manufacturer (Section D): SYMMETRY SURGICAL INC; 3034 owen drive; antioch TN 37013
• MDR Report Key: 8676295
• MDR Text Key: 148412025
• Report Number: 3007208013-2019-00011
• Device Sequence Number: 1
• Product Code: GEN
• UDI-Device Identifier: 00887482069127
• UDI-Public: 00887482069127
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 08/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 32-118
• Device Lot Number: 1403314
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1