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U.S. Department of Health and Human Services

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

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SYNTHES MONUMENT ROD INTRODUCTION PLIERS FOR DUAL-OPENING IMPL F/6.0MM RODS PLIERS, SURGICAL Back to Search Results
Catalog Number 388.509
Device Problem Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/28/2017
Event Type  Malfunction  
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 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).

 
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.

 
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.

 
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Brand NameROD INTRODUCTION PLIERS FOR DUAL-OPENING IMPL F/6.0MM RODS
Type of DevicePLIERS, SURGICAL
Manufacturer (Section D)
SYNTHES MONUMENT
1051 synthes ave
monument CO 80132
Manufacturer (Section G)
SYNTHES MONUMENT
1051 synthes ave
monument CO 80132
Manufacturer Contact
michael cote
1302 wrights lane east
west chester, PA 19380
6107195000
MDR Report Key6421509
MDR Text Key70628509
Report Number1719045-2017-10249
Device Sequence Number1
Product Code HTC
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberEXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 02/28/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/21/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number388.509
Device LOT Number7083789
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer04/25/2017
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/28/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured11/22/2013
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 03/21/2017 Patient Sequence Number: 1
Treatment
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)
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