MAUDE Adverse Event Report: SYNTHES MONUMENT DEPTH GAUGE FOR 1.3MM AND 1.5MM SCREWS; GAUGE, DEPTH

Catalog Number 319.004

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Device is an instrument and is not implanted/explanted.The subject device is expected to be returned to the synthes manufacturer for evaluation.A service and repair record review was attempted for the subject device.The review could not be performed because the device is a lot controlled item.The manufacture date of the subject device is aug 8, 2014.The source of the manufacture date is the release to warehouse date.The subject device was received.The investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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 the tip of the depth gauge was broken.It is unknown when the depth gauge was broken but there was no report of surgical or patient involvement.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

A service and repair evaluation was completed: the customer reported the tip broke off.The repair technician reported tip broken as the reason for repair.The item is not repairable.The cause of the issue is unknown.The item will be forwarded to the complaint handling unit.The evaluation was confirmed.A product investigation was completed: the complaint condition is confirmed as the depth gauge was received with the distal portion of the needle broken off.Although the damage appears to be the result of excessive weight being placed onto the needle during sterile processing, the root cause cannot be definitively determined as the specific conditions at the time of the damage are unknown.The returned part was determined to be suitable for the intended use when employed and maintained as recommended and the risk assessment was found to adequately address the complaint condition.The evaluation found that the depth gauge is intended for use in measuring for 1.3 and 1.5mm screws in various plating systems and is listed in techniques guides for headless compression screws, the modular hand system, and the rotation correction plate system.The depth gauge was received with the distal portion of the needle broken off.All components except the broken portion of the needle (approximately 6.1mm +/-1 per the drawing) were received.There is scraping noted below the product etchings on the outer sleeve and on the needle near the break.The balance device shows surface scratches and worn edges consistent with the expected result from extensive use.Thus, the complaint condition is confirmed and consistent with the reported condition.Replication of the complaint condition is not applicable as the device is already broken.A review of the current design drawing / manufactured revision for the top level assembly and the needle component was performed.The material of the needle component is extra hard 316 stainless steel.The thickness of the needle is driven by the fact that the needle must fit into a drilled hole of 1.1mm, and the length is determined so the slider can measure screws up to 30 mm.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.The returned part was determined to be suitable for the intended use when employed and maintained as recommended.The returned condition is consistent with the result from being subjected to a high force that would not be expected during normal use.There is a protection sleeve to protect the needle during transport and the body that slides on the measuring portion adds additional protection to the needle attachment point during use.Although the damage appears to be the result of excessive weight being placed onto the needle during sterile processing, the root cause cannot be definitively determined as the specific conditions at the time of the damage are unknown.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.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: DEPTH GAUGE FOR 1.3MM AND 1.5MM SCREWS
• Type of Device: GAUGE, DEPTH
• 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: 5297944
• MDR Text Key: 33519365
• Report Number: 1719045-2015-10825
• Device Sequence Number: 1
• Product Code: HTJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 11/25/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 319.004
• Device Lot Number: 7761274
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/18/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/08/2014
• 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