MAUDE Adverse Event Report: SYNTHES USA 5.0MM FLEXIBLE SHAFT; REAMER

Catalog Number 352.040

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

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

Event Date 07/12/2015

Event Type  malfunction  

Manufacturer Narrative

Patient initials are (b)(6).Device is an instrument and is not implanted or explanted.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Investigation could not be completed and no conclusion could be drawn as no device was returned.Without a lot number, the device history record review could not be requested.Device 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 the flexible reamer shaft broke approximately one inch from the tip during a surgical procedure on (b)(6) 2015.The fragment was extracted by reinserting the beaded guide wire and using the extra flexible reamer shaft to ream.The surgeon was able to successfully implant the tibia nail without further incident.A surgical time delay of five (5) minutes was noted.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Product investigation summary: the complaint condition for the 5.0mm flexible shaft (352.040) with unknown lot number was likely caused by years of use and possibly the application of excessive force; however, this complaint is not likely a result of any design related deficiency.The 5.0mm flexible shaft is an instrument routinely used in the flexible reamers for intramedullary nails system.The device was returned and reported to have broken while reaming.This condition is confirmed; the distal portion of the device has broken off at the metal joint approximately four and a half centimeters from the distal tip.It is likely that years of use and possibly the application of excessive force during surgery have led to this complaint condition.The balance of the returned device is in fair condition with some markings at the proximal end of the device over the part and lot number.Drawing was reviewed and determined to be suitable for the intended design, application and dimensional conformity when used as recommended.It is likely that years of use and possibly the application of excessive force during surgery have led to this complaint condition.Device 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.

• Brand Name: 5.0MM FLEXIBLE SHAFT
• Type of Device: REAMER
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): SYNTHES USA
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4997474
• MDR Text Key: 22862750
• Report Number: 2520274-2015-15149
• Device Sequence Number: 1
• Product Code: HTO
• 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: company representative,health
• Reporter Occupation: Other
• Report Date: 07/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 352.040
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/16/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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 Age: 30 YR