MAUDE Adverse Event Report: SYNTHES MONUMENT ROD INTRODUCTION PLIERS FOR DUAL-OPENING IMPL F/6.0MM RODS; PLIERS, SURGICAL

Catalog Number	388.509
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/28/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is an instrument and is not implanted/explanted.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.A device history record (dhr) review was performed on part # 388.509, lot # 7083789: release to warehouse date: 22nov2013, expiration date: na, manufacturing site is (b)(4) and supplied by (b)(4).A non conformance report (ncr) was issued for missing heat treatment and brazing of the collet and collet handle components.This resulted in the entire batch (qty (b)(4)) being returned to the supplier and scar being issued.This ncr is potentially related to the complaint condition.Review of the device history record(s) showed that there are potential issues during the manufacture of the product that would contribute to this complaint condition.Service history review (shr) was performed on part#388.509, lot#7083789: no service history review can be performed as part number 388.509 with lot number(s) 7083789 is a lot/batch controlled item.The manufacture date of this item is 5-feb-2013.The source of the manufacture date is the release to warehouse date.The service history review is unconfirmed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 during a procedure as the surgeon was placing the rod and attaching it to the universal spine system ii (ussii) screw with the appropriate ti collar using the pliers, the flange on the sleeve broke off.Fragments were generated from the broken device and easily removed without additional intervention.The surgeon was able to attach the collar despite the instrument breaking.During final tightening of the construct, two instruments, the hexagonal screwdriver and wrench stripped and it became difficult to tighten the locking washers.The surgeon was able to use a mallet and position the instruments in order to complete the final tightening of the construct.The procedure was successfully completed without delay and no harm to the patient.Concomitant medical products: unknown rod (part # unknown, lot # unknown, quantity 1); ussii screw (part # unknown, lot # unknown, quantity 1); ti collar (part #unknown, lot# unknown, quantity, 1); locking washer (part# unknown, lot# unknown, quantity, unknown).This is report 1 of 1 for complaint (b)(4).
Additional Manufacturer Narrative
(b)(6).A service and repair evaluation was performed on the returned subject device.The customer reported the flange on the sleeve broke off.The repair technician reported the collet broke in half at the weld point.Damaged component is the reason for repair.The item is not repairable per the inspection sheet.The cause of the issue is unknown.The item will be forwarded to customer quality.The evaluation was confirmed.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.
Additional Manufacturer Narrative
A product investigation was performed.This complaint is confirmed.This investigation summary was performed from photos provided for one of the three complaint parts.Only photos were provided for device part # 388.509 (rod introduction pliers).Devices 388.335 (hexagonal screwdriver) and 03.602.042 (torque limiting wrench ) were not returned and photos were not provided and therefore an investigation could not be performed at customer quality (cq).Part # 388.509 rod introduction pliers for dual-opening impl f/6.0mm rods: a visual inspection of the provided photos, device history record (dhr) review and drawing review were performed as part of this investigation.As reported, the collet has broken off at the location it is secured to the rest of the pliers.One (1) non conformance report (ncr) was issued for missing heat treatment and brazing of the collet and collet handle components.This resulted in the entire batch (qty 4) being returned to the supplier.Review of the device history record(s) showed that there are potential issues during the manufacture of the product that would contribute to this complaint condition.The parts missing heat treat were returned to the supplier, not used as is.Relevant drawings were reviewed during this investigation.No product design issues or discrepancies were observed.Whether this complaint can be replicated at customer quality (cq) is not applicable for this complaint condition as the photos show device is already broken.No new malfunctions were identified as a result of the investigation.No new, unique or different patient harms were identified as a result of this evaluation.The returned part was determined to be suitable for the intended use when employed and maintained as recommended.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: ROD INTRODUCTION PLIERS FOR DUAL-OPENING IMPL F/6.0MM RODS
• Common Device Name: PLIERS, SURGICAL
• Manufacturer (Section D): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• MDR Report Key: 6421509
• Report Number: 1719045-2017-10249
• Device Sequence Number: 16312379
• Product Code: HTC
• UDI-Device Identifier: 10705034773339
• UDI-Public: (01)10705034773339(10)7083789
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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,Followup
• Report Date (Section B): 02/28/2017

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: 388.509
• Device Lot Number: 7083789
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/28/2017
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 03/21/2017
• Supplement Report FDA Received Date: 04/28/2017; 05/02/2017
• 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: LOCKING WASHER (PART & LOT# UNKNOWN, QTY UNKNOWN); ROD (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1); TI COLLAR (PART #UNKNOWN, LOT# UNKNOWN, QTY 1); USSII SCREW (PART # UNKNOWN, LOT # UNKNOWN, QTY 1)
• Patient Age: 60 YR