MAUDE Adverse Event Report: SYNTHES MONUMENT COMPRESSION FORCEPS; INSTRUMENT COMPRESSION

Catalog Number	03.211.400
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/29/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is an instrument and is not implanted/explanted.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.A review of the device history records has been requested.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 while setting up for an initial tarsometatarsal (tmt) arthrodesis procedure on (b)(6) 2017, the scrub tech discovered that the spring in the compression forceps that allows the device to open is broken but still attached to the forceps.No issues with the device prior to discovery.It is unknown how long the device has been in use.A backup forceps was offered to the surgeon.However, surgeon continued to use the defective forceps in surgery.The forceps were used over the patient to compress against two compression wires.There were no fragments generated.Standard x-rays taken during procedure confirm there were no fragments in the patient.Procedure was successfully completed without requiring medical intervention.No surgical delay reported.Patient status/outcome was reported as stable.Concomitant device reported: wires (part unknown, lot unknown, quantity 2).This report is for one (1) compression forceps.
Additional Manufacturer Narrative
Device history records review was completed for part# 03.211.400, lot# 6622478.Supplier: (b)(4), release to warehouse date: 20 jan 2012.Review of the device history record(s) showed that there are issues during the manufacture of the product that would contribute to this complaint condition.Of the (b)(4) parts, 7 devices failed due to small leaf spring, cracked at m2.5x6 screw.93 remaining parts were released.Product development investigation was completed.A visual inspection, functional test and drawing review were performed as part of this investigation.One compression forceps was returned for investigation.This complaint is confirmed, as the leaf spring on the returned forceps is sheared in half approximately 7.0 mm (calipers ca592) distal to the location where it is secured to the handle with a screw.In addition to the break, there is also a crack in the leaf spring where it is secured to the handle with a screw.Whether this complaint can be replicated is not applicable as returned device is already broken.Relevant drawings were reviewed.No product design issues or discrepancies were observed.The returned instrument(s) are used during forefoot/midfoot variable angle lcp implantations and proper use and maintenance as addressed in technique guide.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.

• Brand Name: COMPRESSION FORCEPS
• Common Device Name: INSTRUMENT COMPRESSION
• Manufacturer (Section D): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• MDR Report Key: 6515899
• Report Number: 1719045-2017-10340
• Device Sequence Number: 1331580
• Product Code: HWN
• UDI-Device Identifier: 10886982076267
• UDI-Public: (01)10886982076267(10)6622478
• Combination Product (Y/N): N
• Initial Reporter State: ND
• 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): 03/29/2017

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: 03.211.400
• Device Lot Number: 6622478
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/29/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/24/2017
• Supplement Report FDA Received Date: 05/19/2017
• 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: WIRE (PART AND LOT UNKNOWN, QUANTITY 2)