MAUDE Adverse Event Report:; REAMER

Device Problem Sticking (1597)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/14/2017

Event Type  malfunction  

Manufacturer Narrative

Patient gender is male, no other information is available for reporting.This report is for unknown reamer bit / unknown lot number.Device is an instrument and is not implanted/explanted.Device is not expected to be returned for manufacturer review/investigation.Without a lot number, the device history record review and the investigation could not be completed; no conclusion could be drawn, as no product was not returned and no lot number was provided.Based on the information available, this complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Device report from synthes on an event in (b)(6) as follows: it was reported that the reported devices were used in the surgery for the femoral trochanteric fracture on (b)(6) 2017.In order to measure the distal diameter for the intra-medullary nail, the medullary canal was used.The lock between the reamer bit and reamer shaft part was confirmed.Since the intramedullary reamer was inserted without using the reaming rod with ball tip, the reamer bit was left near the lesser trochanter.In order to remove the remained reamer bit, the guide rod and depth gauge for distal locking were tried.The four k-wires were used to the proximal 2/3rd of the femur and lesser trochanter to prevent a fall of the reamer bit in question.Eventually, the reamer bit was removed by using the depth gauge.The surgery was extended for 30 minutes.Patient outcome is okay.This complaint involves 1 part.Concomitant devices: 1x tfna femoral nail, 04.037.012s / lot unknown, 1x tfna helical blade, 04.038.300s / lot unknown, 1x tfna end cap, 04.038.010s / lot unknown, 1x synream reaming rod, 351.709s / lot unknown, 4x k-wire, part/ lot number unknown.This report is 1 of 1 for (b)(4).

• Type of Device: REAMER
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6915126
• MDR Text Key: 88236036
• Report Number: 2520274-2017-12398
• Device Sequence Number: 1
• Product Code: HTO
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: H10
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/14/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: 1X SYNREAM REAMING ROD, 351.709S / LOT UNKNOWN; 1X TFNA END CAP, 04.038.010S / LOT UNKNOWN; 1X TFNA FEMORAL NAIL, 04.037.012S / LOT UNKNOWN; 1X TFNA HELICAL BLADE, 04.038.300S / LOT UNKNOWN; 4X K-WIRE, PART/ LOT NUMBER UNKNOWN