MAUDE Adverse Event Report: SYNTHES MONUMENT TAP/REAMER FOR TROCHANTERIC FIXATION NAIL SCREW; TAP,BONE

Catalog Number 357.430

Device Problem Break (1069)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Code Available (3191)

Event Date 10/23/2014

Event Type  Injury  

Event Description

It was reported that t portion was broken outside of the patient and all fragments were retrieved.It was confirmed from reporter that guidewire might have slightly bent due to patient hard bone during right intertrochanteric fracture for intramedullary (im) nail insertion, after placing guidewire into the neck and head, and drilling with appropriate 11mm drill bit and 6-10 step drill the surgeon used the tap/reamer to tap because the patient had hard bone.On removing the tap/reamer, the end of the tap became logged on the nail inside the lag screw opening.The surgeon attempted a forward and backward screwing motion.Surgeon requested a mallet to hit against the handle but was unable to dislodge the tap/reamer.On approximately the second strike against the handle the t portion came off.The surgeon attached a vice grip to the shaft portion that was remaining and tapped it out with the mallet.The lag screw was then inserted and the fracture was compressed in the appropriate fashion.Surgery was successfully completed with 10 minute surgical delay, patient/status outcome was fine.No allegations were reported against lag screw.It was confirmed that same parts were used to complete surgery.This report is 1 of 2 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.Device is an instrument and is not implanted/explanted.The investigation could not be completed; no conclusion could be drawn, as no product was received.There were no mrr¿s, ncr¿s, or complaint related issues with this lot.Or generated during production.Review of the device history record showed precision edge surgical products manufactured the tap/reamer for trochanteric fixation nail screw, part #357.430, and lot #pe01902 on po #(b)(4) for 43 pieces delivered july 15, 2013.Initially, the part conformed to the supplier¿s certificate of conformance, dated july 11, 2013, and synthes final inspection sheet #(b)(4), revision ¿f¿.The parts were released to the warehouse on july 17, 2013.The tap/reamer for trochanteric fixation nail screw was made to the synthes drawing p/n 357.430, revision ¿d¿, released on january 19, 2012.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

A manufacturing investigation was conducted: visual inspection revealed a complete weld joint on both joints.The shaft diameter measured slightly larger than maximum spec (0.014mm over maximum 10.79mm) and the handle hole measured slightly larger than maximum spec (0.002 to 0.021mm larger than the maximum 10.818mm ¿ using pin gauges 10.82 go and 10.84 no-go).The out of spec conditions may have contributed to the failure.Based on the evaluation, the failure is considered confirmed and may have resulted from manufacturing processes.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

The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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

Synthes has initiated further investigation through the corrective action process.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

The surgery completed and surgeon satisfied with outcome.It is possible that the wire may have skived in the femoral head when it was placed thus causing the tap to bind within the nail.

Manufacturer Narrative

(b)(4).Corrected data: adverse event with required intervention to prevent permanent impairment/damage (devices) fields were checked in addition to previously reported product problem category because unanticipated intraoperative x-rays were performed on (b)(6) 2014 due to reported complaint.X-rays were previously reported.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: TAP/REAMER FOR TROCHANTERIC FIXATION NAIL SCREW
• Type of Device: TAP,BONE
• Manufacturer (Section D): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• Manufacturer (Section G): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4254957
• MDR Text Key: 5017592
• Report Number: 1719045-2014-10592
• Device Sequence Number: 1
• Product Code: HWX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/23/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 357.430
• Device Lot Number: PE01902
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/11/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/17/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 50 YR
• Patient Weight: 91