MAUDE Adverse Event Report: SYNTHES MONUMENT IN SITU BENDER-RIGHT; INSTR,BENDING OR CONTOURING

Catalog Number	388.112
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/26/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient height reported as (b)(6).(b)(4).Device is an instrument and is not implanted/explanted.A device history record review was performed on part # 388.112, serial/supplier lot # (b)(6), synthes lot # 4898334: release to warehouse date: (b)(6) 2004, supplier: (b)(6).No non-conformance reports (ncr's) were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.He product that would contribute to this complaint condition.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported that on (b)(6) 2017, during an initial thoracolumbar spinal fusion surgery, the tip of the in situ bender-right broke off.While putting in a 6.0mm hex-end rod 500mm, the surgeon used a pair of in situ benders from the uss system to bend the rod in situ.While doing this, the tip of one of the benders broke off.The piece was easily retrieved from the patient.There was no delay in the case and no harm to the patient.Concomitant devices reported: 6.0mm hex-end rod 500mm (part # 09.633.501, lot # unknown, quantity # 1).This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Device was used for treatment, not diagnosis a product investigation was performed.It was reported that during a thoracolumbar spinal fusion, the tip of the in situ bender-right broke off.While putting in a 6.0mm hex-end rod 500mm, the surgeon used a pair of in situ benders from the uss system to bend the rod in situ.While doing this, the tip of one of the benders broke off.The piece was easily retrieved from the patient.There was no delay in the case and no harm to the patient.The returned device was confirmed to have a broken tip on the non-bent side.In addition, the recesses of both the 'bent' and 'non-bent' sides were found to be worn and deformed.The device has a great deal of surface wear which does not impact functionality.No ncr's were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.A visual inspection, drawing review and dhr review were performed as part of this investigation.The complaint is confirmed.Replication of the complaint condition is not applicable as the device is already broken.No definitive root cause was able to be determined.The device is over 12 years old and shows signs of significant use.The device likely became weakened over many uses and eventually broke.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: IN SITU BENDER-RIGHT
• Common Device Name: INSTR,BENDING OR CONTOURING
• Manufacturer (Section D): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• MDR Report Key: 6347641
• Report Number: 1719045-2017-10128
• Device Sequence Number: 18841688
• Product Code: HXP
• UDI-Device Identifier: 10705034771915
• UDI-Public: (01)10705034771915(10)35481
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/26/2017

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: 388.112
• Device Lot Number: 35481
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/26/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/21/2017
• Supplement Report FDA Received Date: 03/23/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PART # 09.633.501, LOT # UNKNOWN, QUANTITY # 1
• Patient Age: 21 YR
• Patient Weight: 56