MAUDE Adverse Event Report: SYNTHES (USA) LOCKING BOLT MEASURING DEVICE F/TROCHANTERIC FIXATION NAILS; GAUGE, DEPTH

Catalog Number 357.402

Device Problems Break (1069); Material Fragmentation (1261)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 03/03/2017

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Device is an instrument and is not implanted/explanted.The subject device is expected to be returned to the synthes manufacturer for evaluation but has not yet been received.The investigation could not be completed; no conclusion could be drawn, as no product was received.Without a lot number the device history records review could not be completed.The date of manufacture is unknown.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 trochanteric fixation nail (tfn) procedure on (b)(6) 2017 to treat a right hip fracture, while the surgeon was drilling for the distal inter-locking screw and introducing the locking bolt measuring depth gauge, the depth gauge broke into two pieces.The tip of the depth gauge was not retrievable and remains in the patient.There was no surgical delay and no surgical or medical intervention.The surgery was successfully completed and the patient status outcome is unknown.Concomitant medical products: 11mm/130 deg titanium (ti) cann trochanteric fixation nail 340mm/right sterile ¿ part# 456.414s, lot# - unknown, quantity# - 1; 11.0mm titanium (ti) helical blade 95mm ¿ part# - 456.304, lot# - unknown, quantity# - 1; and 5.0mm titanium (ti) locking screw 40mm - part# 458.940, lot# - unknown, quantity# - 1, and unknown locking bolt measuring device - part# - unknown, lot# - unknown, quantity# - 1.This report is 1 of 1 for (b)(4).

• Brand Name: LOCKING BOLT MEASURING DEVICE F/TROCHANTERIC FIXATION NAILS
• Type of Device: GAUGE, DEPTH
• Manufacturer (Section D): SYNTHES (USA); 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6434567
• MDR Text Key: 70857766
• Report Number: 2520274-2017-11066
• Device Sequence Number: 1
• Product Code: HTJ
• UDI-Device Identifier: 10886982196255
• UDI-Public: (01)10886982196255(10)454272
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 357.402
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/03/2017
• Initial Date FDA Received: 03/24/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: 456.304, 11.0MM TI HELICAL BLADE 95MM, QTY 1; 456.414S, 11MM/130 TI CAN TFN 340MM STERILE, QTY 1; 458.940, 5.0MM TI LOCKING SCREW 40MM, QTY 1; UNKNOWN LOCKING BOLT MEASURING DEVICE, QTY 1
• Patient Outcome(s): Required Intervention