MAUDE Adverse Event Report: SYNTHES MONUMENT DRIVE SHAFT-MINIMUM 520MM LENGTH-FOR USE WITH RIA; REAMER

Catalog Number 314.743

Device Problem Break (1069)

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

Event Type  malfunction  

Manufacturer Narrative

It is unknown if there was patient involvement.Device is an instrument and is not implanted/explanted.Device history record: part 314.743 lot 7353282: released 7 november 2013.(b)(4) manufactured the drive shaft ¿ minimum 520 mm length ¿ for use with ria.The supplier¿s certificate of compliance indicates the parts were manufactured and met the required specifications.The lot was inspected and conformed to the synthes, tabulated incoming final inspection sheet.No non-conformance reports were generated for this lot.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 (b)(4) reports an event in (b)(6) as follows: it was reported the tip of driver shaft broken.It is unknown when the device broke.(b)(4).

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.

Manufacturer Narrative

(b)(6).Product investigation summary: precautionary statements are being added to the technique guide because the ria drive shaft, tube assembly, and reamer head have the potential to break when incorrectly assembled or used improperly.Returned devices include: part 314.743 / lot 7312607 - tip broken off; damage not possible to measure; part 314.743 / lot 7353282 - tip broken off; damage not possible to measure; part 314.742 / lot 14662-01 - tip broken off; damage not possible to measure; part 314.742 / lot 14951-01 - marks of wear and tear on the tips.The review according the material and manufacturing documents has shown that the present ria drive shafts meet all the requirements and specifications.The exact reason for the problem that occurred cannot be determined without further information.Per the technique guide, a drill head is to be selected for bone graft which is 1.0 mm to 1.5 mm larger than the diameter of the medullar canal in the isthmus.That being said, it is likely that the event were caused by a mechanical overload.The overload has exceeded the load limit of the material, which finally led to material failure.The fracture surface is homogeneous, indicating proper material quality.No product fault was found.A device history record and manufacturing documents review was conducted.No complaint related issues were found.A visual inspection has shown that the tip broke off with signs of wear and tear.As no product fault could be detected, no further action required.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.

• Brand Name: DRIVE SHAFT-MINIMUM 520MM 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: 5084772
• MDR Text Key: 26487614
• Report Number: 1719045-2015-10601
• 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: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Followup
• Report Date: 09/04/2015

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: 314.743
• Device Lot Number: 7353282
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/17/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/03/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/07/2013
• 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