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

Catalog Number 314.743

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 01/29/2014

Event Type  malfunction  

Event Description

It was reported that during a procedure with third party products the surgeon was using a synthes reamer irrigator aspirator when the instrument broke apart inside the patient.The surgeon was able to remove everything except three pieces out of the patient.The reporter was unaware if a future revision surgery was scheduled to explant the remaining fragments.The surgeon was able to successfully complete the procedure.There was a 30 minute delay in completing the procedure due to the reported event.Regular reamers were used and a nail was placed in the bone.This is report 3 of 3 for complaint (b)(4).

Manufacturer Narrative

Synthes lot number 6170571 & 5873442; supplier lot number 15803-01.Device is an instrument and is not implanted/explanted.Criterion instrument manufactured the drive shaft ¿ minimum 520mm, p/n 314.743, lot # 6170571 & 5873442 (supplier lot # 15803-01).Supplier lot # 15803-01: 99 parts, per work order.The lot conformed to p/n 314.743 specifications, as noted in the two certificates of compliance (dated may 04, 2011 and september 04, 2008).The lot was inspected and conformed to the synthes incoming final inspection sheet number 314fi741.There were no mrrs, ncrs, or complaint-related issues with this lot.99 parts were released to the warehouse on may 09, 2011.Supplier lot # 6170571, work order indicates destroy label / packaging as required, pack label, release to the warehouse on june 24, 2009.Supplier lot # 5873442: po for 99 parts.The lot conformed to p/n 314.743 specifications, as noted in the certificate of compliance (dated september 04, 2008).The lot was inspected and conformed to the synthes incoming final inspection sheet number 314if741.There were no mrrs, ncrs, or complaint-related issues with this lot.99 parts were released to the warehouse on september 09, 2008.Placeholder.

• Brand Name: DRIVE SHAFT-MINIMUM 520MM LENGTH-FOR USE WITH RIA
• Type of Device: REAMER
• Manufacturer (Section D): SYNTHES MONUMENT; 1101 synthes ave; monument CO 80132
• Manufacturer (Section G): SYNTHES MONUMENT; 1101 synthes ave; monument CO 80132
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 8006207025
• MDR Report Key: 3647884
• MDR Text Key: 4284165
• Report Number: 1719045-2014-00121
• Device Sequence Number: 1
• Product Code: HTO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K013527
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 01/29/2014

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: 15803-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/29/2014
• Initial Date FDA Received: 02/26/2014
• Was Device Evaluated by Manufacturer?: No
• Patient Sequence Number: 1
• Patient Age: 54 YR
• Patient Sex: Female
• Patient Weight: 84 KG