MAUDE Adverse Event Report: SYNTHES USA 12.0MM REAMER HEAD-STERILE FOR REAMER/IRRIGATOR/ASPIRATOR

Catalog Number 352.250S

Device Problems Material Fragmentation (1261); Mechanical Jam (2983)

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

Event Date 05/16/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device is an instrument and is not implanted/explanted.When the returned devices were being investigated by the manufacturer, it was noted that reamer head was also returned and met reportable complaint criteria.(b)(6).A product investigation was completed: the reamer/irrigator/aspirator (ria) technique guide addresses recommended use and information on care and maintenance is provided per the processing synthes reusable medical devices ¿ instruments, instrument trays, and cases.The returned part was determined to be suitable for its intended use when employed and maintained as recommended.During use, the drive shaft is attached to the corresponding length reamer/irrigator/aspirator (ria) tube assembly and a reamer head and then connected to a drive unit.The ria system is intended for use to clear the medullary canal, to size the medullary canal, to harvest bone and bone marrow, and to remove infected and necrotic bone.The drive shaft was received with the distal tip broken off.The broken fragment could be found in the returned reamer head that was still attached to the metal retainer of the tube assembly.The rest of the tube assembly was not returned.Upon further inspection, it was noted that one of the fingers of the reamer head was inside the drive shaft and the drive shaft was cracked vertically at the location of the misplaced reamer head finger.The tube assembly¿s retainer could not be separated from the reamer head.Replication of the complaint is not applicable as the device was returned broken, stuck, and damaged.Although the part number of the reamer head was not provided, the complaint description states that a 12mm reamer head was used which is consistent with the measurements for part 352.250s product drawing.The part number of the tube assembly cannot be confirmed as the retainer is the same for the two available tube assemblies (parts 314.745s and 314.746s).A device history record review could not be performed at the time of investigation as the lot numbers of the reamer head and the tube assembly is unknown.Product drawings for the drive shaft were reviewed.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.No non-conformance reports were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any subcomponents, which would contribute to this complaint condition.The complaint condition is the result of an overload of forces to the distal end of the drive shaft resulting in stresses beyond the failure limit of the shaft.Improper assembly of the reamer head into the drive shaft likely contributed to the drive shaft cracking and the three devices jamming.However, the root cause could not be definitively determined as the circumstances at the time of the break are unknown.The design is adequate for its intended use when used and maintained as recommended, it did not contribute to the complaint condition.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

Device report from synthes europe reported an event in (b)(6) as follows: it was reported that during a bone graft collection procedure for a right femoral nail implantation to treat a (b)(6) proximal femoral lesion on (b)(6) 2016, it was observed that the reamer/irrigator/aspirator (ria) system reamer head had disengaged from the reamer shaft.The event occurred at the end of the reaming process as the ria instruments were being removed from the patient's femur.Upon closer inspection, it was discovered that one of the tines at the end of the reamer shaft had broken off and was retained in the 12mm reamer head.The reported event resulted in an approximate five minute surgical delay.There was no adverse outcome for the patient according to the surgeon and the bone graft had been collected successfully.The surgery was completed without further issue.This is report 2 of 2 for (b)(4).

• Brand Name: 12.0MM REAMER HEAD-STERILE FOR REAMER/IRRIGATOR/ASPIRATOR
• Type of Device: REAMER
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: terry callahan ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5782004
• MDR Text Key: 49155694
• Report Number: 2520274-2016-13411
• Device Sequence Number: 1
• Product Code: HTO
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: K111437
• 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: 05/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 352.250S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/17/2016
• 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