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

Catalog Number 314.743

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

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

Event Date 08/20/2015

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.(b)(6).Device is an instrument and is not implanted/explanted.The investigation could not be completed; no conclusion could be drawn, as no product was received.A review of the device history records was requested for the subject device lot.It was reported that the subject device would not be returned for evaluation.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 during a trochanteric fixation nail insertion, while the surgeon was reaming with the power in ream mode, the tip of the drive shaft broke off.It was reported that the patient had hard bone.A standard reamer was immediately available to complete the procedure.The tip was removed and no fragments were retained in the patient.There was no surgical delay or patient harm reported.This report is 1 of 1 for com-(b)(4).

Manufacturer Narrative

Additional manufacturing dates include june 24, 2009.Device history review: criterion tool & die manufactured the drive shaft, minimum 520mm length, for use with ria (part 314.743 / lot 15803-01) for 99 parts for one work order and 99 parts for another.The rework form (dated (b)(4) 2011) indicated ¿etch ¿ce¿ mark and passivate.Rework of criterion manufactured part 314.743 / lot 5873442 (original lot 6170571, repacked by synthes).The certificate of compliance (c of c), dated may 4, 2011, indicates lot 15803-01 was passivated per the synthes drawing.The second c of c (dated september 4, 2008) indicated the lot was manufactured and conformed to specifications per the associated synthes drawing.Lot 15803-01 was inspected and conformed to the synthes incoming final inspection tabulated sheet.There were no complaint-related issues, material record reports, or non-conformance reports associated with this lot.99 parts were released to the warehouse on (b)(4) 2011.Lot 6170571 for 99 parts was for ¿destroy label / package as required, pack / label per lppf¿, and indicated 99 parts were released to the warehouse on june 24, 2009.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: 5047057
• MDR Text Key: 24769097
• Report Number: 1719045-2015-10568
• 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,health
• Reporter Occupation: Other
• Report Date: 08/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2015
• 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: 15803-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/02/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/09/2011
• 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: 56 YR