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

Catalog Number 319.006

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Date 10/26/2015

Event Type  malfunction  

Manufacturer Narrative

There was no patient involvement.Device is an instrument and is not implanted/explanted.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.Part 319.006, lot 6004399: manufacturing location: (b)(4).Manufacturing date: 20october2008.No non-conformance reports were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the 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.

Event Description

It was reported that while prepping for a revision of the first metatarsal the tip of a depth gauge broke off.The surgical team was preparing for the surgery to revise the patient, removing the non-synthes implant and replacing it with a synthes device.The patient, previously implanted with an unknown non-synthes device, had not been brought into the room.It was noted preoperatively that the tip protector on the depth gauge to protect the tip from breaking off was not all the way on.While the device was being removed from the set the tip protector was inadvertently hooked on the set and broke off.A backup set was available and used to complete the surgery.There was no patient impact.There were no surgical delays or medical intervention required.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Device investigation summary ¿ one of the following was received: depth gauge (part # 319.006 | lot # 6004399).The returned depth gauge shows regular use during its 7+ year lifespan.The hooked needle stem of the device is broken off at the base of the black body (the broken stem is approx.75mm in length) and was returned.The depth gauge is part of 2.4 mm variable angle lcp distal radius system and is 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.The information is provided per the 2.4 mm variable angle lcp distal radius system technique guide j8301-i.The damage is the result of excessive force due to the tip protector not being properly attached to the device.This complaint is confirmed.Device drawings 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.As noted in prior complaints, the thickness of the needle (1.25 mm) is driven by the fact that the needle must fit into a drilled hole of 1.5 mm, and the length (80 mm) is determined so the slider can measure screws up to 40 mm.The material of the needle probe component is extra hard 316ss, which is an appropriate material for an instrument component of this type.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 BRANDYWINE; 1303 goshen parkway; west chester PA 19380
• Manufacturer (Section G): SYNTHES BRANDYWINE; 1303 goshen parkway; west chester PA 19380
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5211182
• MDR Text Key: 30780460
• Report Number: 2530088-2015-10690
• 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
• Type of Report: Initial,Followup
• Report Date: 10/26/2015

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: 319.006
• Device Lot Number: 6004399
• Other Device ID Number: (01)10886982189943(10)6004399
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/26/2015
• Initial Date FDA Received: 11/09/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/24/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/20/2008
• 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