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

Catalog Number	32-118
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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
• Common Device Name: SIDE CUTTING FORCEPS
• Manufacturer (Section D): SYMMETRY SURGICAL INC; 3034 owen drive; antioch TN 37013
• MDR Report Key: 8676295
• Report Number: 3007208013-2019-00011
• Device Sequence Number: 16708480
• Product Code: GEN
• UDI-Device Identifier: 00887482069127
• UDI-Public: 00887482069127
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 32-118
• Device Lot Number: 1403314
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 02/28/2019
• Supplement Date Received by Manufacturer: 02/28/2019
• Initial Report FDA Received Date: 06/06/2019
• Supplement Report FDA Received Date: 08/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1