MAUDE Adverse Event Report: SYNTHES MONUMENT DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS; GAUGE,DEPTH

Catalog Number 319.006

Device Problem Break (1069)

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

Event Date 06/05/2017

Event Type  malfunction  

Manufacturer Narrative

Patient information was not provided for reporting.Device is an instrument and is not implanted/explanted.Device is expected to be returned for manufacturer review/investigation, but has not been received yet.Reporter contact number (b)(6).Device history records review was completed for part# 319.006, lot# 6602084.Manufacturing location: (b)(4), manufacturing date: feb 28, 2011.Materials records review (mrr) was generated or (b)(4) undersized subcomponents during production.Destructive testing was performed and based on the evaluation of the data as well as intended use of the devices; there is no safety or functional concerns with the out of specification components.Relevance to complaint condition cannot be determined until the product is returned for investigation.Review of the device history record showed that there were potential issues during the manufacture of this product that would contribute to this complaint condition.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

(b)(6) reported that on (b)(6) 2017, patient underwent open reduction internal fixation of the ankle.During the procedure, the probe of the depth gauge broke off and fell inside the patient as the surgeon was advancing it to obtain measurement.The broken probe was easily retrieved by surgeon picking it up with fingers, with no fragments remaining in the patient.There was no reported surgical delay, and another depth gauge was available to use to complete the procedure.There was no reported harm to the patient.This report is for one (1) depth gauge for 2.0mm and 2.4mm screws.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Additional narrative: a product investigation was completed: the 319.006, lot number 6602084, depth gauge for 2.0mm and 2.4mm screws was returned with the needle component broken off of the depth gauge.This complaint is confirmed.The needle component was observed to be slightly bent.The protection sleeve component was observed to be missing from the instrument.A visual inspection, dhr review, and drawing review were performed as part of this investigation.This 319.006 depth gauge for 2.0mm and 2.4mm screws is an instrument routinely used to measure the depth of the holes for the 2.0mm/2.4mm screws to ensure the correct screw length is used during the procedure.Although a definitive root cause could not be determined, this complaint condition is likely due to repeated usage of the instrument, leading to cumulative wear, exposure to various intra-operative forces and exposure to several sterilization (thermal) cycles throughout the service life of the device.Additionally, this condition can be possibly due to bending force(s) applied to the needle component beyond the yield limit of the material.The protection sleeve was likely misplaced during sterile processing.The relevant drawings were reviewed and determined to be suitable for the intended design, application and dimensional conformity when used as recommended.The device history record had identified a potential issue related to the complaint condition.That was investigation and it was determined, the bending strength of an external thread element would be a function of the size of the minor diameter, not the major diameter since the minor diameter represents the worst case cross section in terms of bending strength.Therefore the non-conformance report is not relevant to the complaint condition.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 2.0MM AND 2.4MM 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: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6651226
• MDR Text Key: 77938408
• Report Number: 1719045-2017-10581
• Device Sequence Number: 1
• Product Code: HTJ
• UDI-Device Identifier: 10886982189943
• UDI-Public: (01)10886982189943(10)6602084
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 319.006
• Device Lot Number: 6602084
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/28/2011
• 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