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 04/11/2017

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional device product code is hrx.Device is an instrument and is not implanted/explanted.(b)(6).The subject device was received.The investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.A device history record (dhr) review for the reported subject device lot has been requested.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Synthes europe reported an event in the (b)(6) as follows: it was reported that whilst using the reamer/irrigator/aspirator (ria) the drive shaft splintered.A metal fragment from the broken drive shaft got stuck in the tibia which had to be removed as it was blocking the continuation of reaming.The fragment was removed allowing continuation of the reaming.The surgery was prolonged approximately 20 minutes.There was no adverse consequence to the patient.The surgery was successfully completed.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

A device history record review was performed for the subject device lot number 7312608.Supplier: (b)(4).Date of manufacture: 19 aug 2013.The review showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.No non-conformances were generated during the production of the subject device.A manufacturing investigation was performed for the subject device (drive shaft-minimum 520 mm length-for use with ria, part number 314.743, lot number 7312608).The subject device was returned to the manufacturer with the complaint condition stating: during the investigation, no product design issues or discrepancies were observed that may have contributed to the complaint condition.A visual inspection under 5x magnification, device history record (dhr) review, and drawing review were performed as part of this investigation.This complaint is confirmed, as the distal tip of the ria is broken off.Although a definitive root cause could not be determined, the complaint condition was most likely caused by force applied to the distal end of the drive shaft, resulting in stresses beyond the failure limit.Other clinical factors such as the patient¿s condition and physical attributes could have impacted the positioning of the instrument, or lateral forces during surgery, that are unable to be replicated in the cq, may have been acting on the instrument.The drive shaft was received with the distal tip, which mates with the reamer head, broken off.The broken portion was not received.The break is located approximately 5.78 to 8.96 mm distal to the distal edge of the drive shaft helix.The helix is intact and in good condition.Additionally, the device also has minor surface wear which does not impact functionality.Replication of the complaint condition is not applicable as the device was received in broken condition.Measurements taken with calipers.The following drawings for the device were reviewed, and no drawing issues or discrepancies were noted.The design is adequate for its intended use and did not contribute to this complaint condition.The complaint condition was most likely caused by force applied to the distal end of the drive shaft resulting in stresses beyond the failure limit.Other clinical factors such as the patient¿s condition and physical attributes could have impacted the positioning of the instrument, or lateral forces during surgery, that are unable to be replicated in the cq, may have been acting on the instrument.The root cause could not be definitively determined as the circumstances at the time of the break are unknown.It is not likely that the design of the device contributed to this complaint.No new, unique or different patient harms were identified as a result of this evaluation.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: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6553349
• MDR Text Key: 74698975
• Report Number: 1719045-2017-10440
• Device Sequence Number: 1
• Product Code: HTO
• UDI-Device Identifier: 07611819739208
• UDI-Public: (01)07611819739208(10)7312608
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042899
• 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: Initial,Followup
• Report Date: 04/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2017
• 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: 7312608
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/15/2017
• 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