MAUDE Adverse Event Report: SYNTHES MONUMENT DRIVE SHAFT-MINIMUM 360MM LENGTH-FOR USE WITH RIA; REAMER

Catalog Number 314.742

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

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

Event Date 06/30/2015

Event Type  malfunction  

Event Description

Device report from synthes (b)(4) reported an event in (b)(6) as follows: it was reported that the tip of the drive shaft was found to have been sheared off when the instrument set was opened during surgery.The patient was on the operating table but the surgical procedure had not yet begun (no incision had been made).This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional narrative: patient information was not provided by reporter.Device is an instrument and is not implanted/explanted.(b)(6).The investigation could not be completed; no conclusion could be drawn, as no product was received.A review of the device history records has been requested.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Device was used for treatment, not diagnosis.A manufacturing investigation was performed for the subject device (part number 314.742, drive shaft-minimum 360mm length-for use with ria, lot number 14563-01).The subject device was received with the hexagon broken off.The helix is completely stripped and there are stress marks visible at the shaft.The measurable dimensions of the ria drive shaft were checked as far as possible and found to be in compliance with the technical drawings and the specifications.The manufacturing documents were reviewed and no complaint related issues were detected.Based on the provided information the exact cause of this occurrence could not be determined but it is likely that a mechanical overload caused this breakage.Next to the broken hexagon, it was discovered that the drive shaft has stress marks and that the helix at the forefront of the shaft is completely stripped.Afterwards it cannot be defined if these damages occurred due to a metallic contact or excessive use over the years (manufactured in 2006), but they are also an indication for a mechanical overload.The complaint condition was confirmed but no product fault could be detected.A root cause could not be definitively determined.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Subject device has been received and is currently in the evaluation process.Investigation is ongoing; no conclusion could be drawn as product is entering the complaint system.Device history records was conducted.The report indicates that the: criterion tool & die, inc.Manufactured the drive shaft - minimum 360mm length - for use with ria (reamer / irrigator / aspirator) p/n 314.742, lot # lot # 5309787, supplier lot # 14563-01, per po # 656698, dated august 07, 2006, for 50 parts.The certificate of compliance and the certificate of conformance, both dated august 04, 2006, indicated the lot was manufactured and conformed to specifications, per drawing number 314.742, revision "g".The lot was inspected and conformed to the synthes tabulated incoming final inspection sheet number 314if741, revision "f".There were no mrr, ncrs, or complaint-related issues with this lot.50 parts were released to the warehouse on august 17, 2006.The lot was manufactured to the synthes tabulated drawing p/n 314.741, revision "g", released on april 10, 2006 (which includes part numbers 314.741, 314.742, and 314.743).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: DRIVE SHAFT-MINIMUM 360MM LENGTH-FOR USE WITH RIA
• Type of Device: REAMER
• 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: 4918964
• MDR Text Key: 6031156
• Report Number: 8030965-2015-11232
• Device Sequence Number: 1
• Product Code: HTO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK042899
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,company representati
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 07/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 314.742
• Device Lot Number: 14563-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/20/2015
• Initial Date FDA Received: 07/16/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/03/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/17/2006
• 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