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

Catalog Number 319.006

Device Problems Break (1069); Material Fragmentation (1261); Dull, Blunt (2407)

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

Event Date 11/24/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(6).(b)(4).Device is an instrument and is not implanted or explanted.Investigation could not be completed and no conclusion could be drawn as no device was returned.Without a lot number, the device history record review could not be requested.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.

Event Description

It was reported that the silver tip of a 1.5mm threaded drill guide with depth gauge was broken upon opening a set during a surgical procedure on (b)(6) 2015.Additionally, the threads appeared to be stripped and would not lock into the plate.No additional information available pertaining to patient outcome or surgical delay.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.A service and repair history record review has been requested and the results are pending completion.The investigation could not be completed; no conclusion could be drawn, as no product was yet been received.The subject device is expected to be returned to the synthes manufacturer 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

Additional information was received on (b)(6) 2015 with clarification reporting that the previously complained depth gauge is actually part number 319.006, depth gauge for 2.00mm and 2.4mm screws.The tip was found broken upon opening the set during a surgical procedure as previously reported.It was further reported that there was no surgical delay due to the reported issue and that a back-up instrument was available for use.The surgery was successfully completed.

Manufacturer Narrative

Subject device has been received; no conclusions could be drawn as the device is entering the complaint completion.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.

Manufacturer Narrative

A product investigation was completed: the complaint condition of broken tip is confirmed as upon visual inspection the hooked needle stem of the device is broken off as the base of the black body (the broken stem is approximately 75mm in length).The complaint device shows light wear consistent with use during its 2 year lifespan.The damage appears to be the result of rough handling/excessive force; the exact cause could not be identified.Per the technique guide, the 319.006 depth gauge is an instrument routinely used in the 2.4mm lcp distal radius system to measure screw length.The device history record was reviewed.No non-conformance reports were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture.The relevant drawings were reviewed.The design history was found to not impact the complaint condition.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 damage appears to be the result of rough handling/excessive force; the exact cause could not be identified.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.

Manufacturer Narrative

Service history review: part no.319.006, lot no: 9897681: a service history of the past three years has been reviewed.No service history review can be performed.The item has not previously been in for service.There is no information relevant to the current complained issue.The manufacture date of this item is october 06, 2015.The source of the manufacture date is the release to warehouse date.The service history evaluation is unconfirmed.Part number: 319.006, lot number: 9897681: release to warehouse date: october 6, 2015.Manufactured by synthes (b)(4).No non-conformance reports were generated during production for this assembly or relevant components.Review of the device history record(s) showed that there were no issues during the manufacture of this product that would contribute to this 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: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5297443
• MDR Text Key: 33494091
• Report Number: 2520274-2015-17899
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,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: 319.006
• Device Lot Number: 9897681
• Other Device ID Number: (01)10886982189943(10)9897681
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/28/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/06/2015
• 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: 31 YR
• Patient Weight: 78