MAUDE Adverse Event Report: SYMMETRY SURGICAL INC. KERRISON RONGEUR

Model Number 58-3200J-BD

Device Problem Missing Value Reason (3192)

Patient Problem Missing Value Reason (3192)

Event Date 09/09/2015

Event Type  No Answer Provided  

Manufacturer Narrative

Device was sent back to the supplier, supplier received the device on (b)(6) 2015, in order for evaluation to begin.Symmetry has not received the device back from the supplier - we will submit a follow up report once received.

Event Description

Screw kept coming out, and fell into the patient.It was recovered.Item needs to be evaluated and replaced as soon as possible.

Manufacturer Narrative

Device was sent back to the supplier, supplier received the device on 10/23/2015 in order for evaluation to begin.Symmetry has not received the device back from the supplier.We will submit a follow up report once received.Follow-up: device was sent to the supplier for evaluation, supplier located in (b)(4), they responded to symmetry's inquiry stating: supplier improved the screw locking laser welding spots.Supplier also updated their internal work instruction to include additional weld spots four weld places are now identified on the locking screw mechanism.

Event Description

Screw kept coming out, and fell into the patient.It was recovered.Item needs to be evaluated and replaced as soon as possible.

• Brand Name: KERRISON RONGEUR
• Manufacturer (Section D): SYMMETRY SURGICAL INC.; 3034 owen dr; antioch TN 37013
• Manufacturer (Section G): SYMMETRY SURGICAL INC.; 3034 owen dr; antioch TN 37013
• Manufacturer Contact: victoria rogers ; 3034 owen dr; antioch, TN 37013 ; 8002513000
• MDR Report Key: 5246959
• MDR Text Key: 32263632
• Report Number: 3007208013-2015-00030
• Device Sequence Number: 1
• Product Code: HTX
• UDI-Device Identifier: 00887482102527
• UDI-Public: 00887482102527
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 11/09/2015

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
• Device Operator: Other
• Device Model Number: 58-3200J-BD
• Device Catalogue Number: 58-3200J-BD
• Device Lot Number: 81408542
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/19/2015
• Initial Date Manufacturer Received: 10/19/2015
• Initial Date FDA Received: 11/10/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/15/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1