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

Catalog Number 319.006

Device Problem Component Missing (2306)

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

Event Date 07/12/2016

Event Type  malfunction  

Manufacturer Narrative

Additional narrative: patient initials are (b)(6).Patient weight is unknown.Device is an instrument and is not implanted or explanted.Service and repair evaluation: the customer reported the item was missing the ball within the depth gauge; the repair technician reported the ball stop was missing and would not stay in the sleeve.Missing parts is the reason for repair.The item is not repairable per the inspection sheet.The cause of the issue is unknown.The item will be forwarded for further investigation.Service history record review: no service history review can be performed as part 319.006 with lot 5032793 is a lot/batch controlled item.The manufacture date of this item is july 14, 2005.The source of the manufacture date is the release to warehouse date.The service history review is unconfirmed.Device history record review: manufactured by synthes (b)(4) - release to warehouse date: july 14, 2005.A non-conformance report (ncr) was written for a stock hold due to an undersized major diameter on the needle components part 319.004.03.This ncr is not relevant to this complaint because this complaint is for a missing ball component.Review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.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 originally reported that a depth gauge would not slide smoothly during an open reduction internal fixation (orif) procedure of a fracture on (b)(6) 2016.Another instrument was available for use to complete the procedure.No reported delay or patient harm was noted.On (b)(6) 2016, it was further reported that a second depth gauge used during the same procedure was missing a component.Without the reported ball, the device would not allow for resistance.Upon review of the returned devices, the repair technician noted that the gauge with lot 7393583 had a bent and broken tip.This report is 2 of 2 for (b)(4).

Manufacturer Narrative

A product investigation was completed: two depth gauge for 2.0mm and 2.4mm screws (part 319.006, lot 7393583 and 5032793) were returned for investigation.Device 7393583 was received in multiple pieces.The hooked needle stem of the device is broken off at the base of the black body (the broken stem is approximately 75mm in length) and was not returned.Device 5032793 was returned intact, but the ball bearing and spring are missing from the slider body.The exact cause for both complaint conditions cannot be determined.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.A visual inspection, functional test, complaint history review, drawing review, and risk assessment review were performed as part of this investigation.No product design issues or discrepancies were observed.This complaint is confirmed.This particular depth gauge is part of at least 14 technique guides, including the 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 relevant drawings for the device(s) were reviewed.No drawing issues or discrepancies were noted.The design is adequate for its intended use and did not contribute to this complaint condition.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.The design, materials and finishing processes were found to be appropriate for the intended use of these devices.A review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.The root cause of the complaint condition is unknown.No manufacturing or design issues were noted during the investigation.The design is determined to be adequate for its intended use when used and maintained as recommended.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: terry callahan ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5850915
• MDR Text Key: 51345715
• Report Number: 2530088-2016-10212
• Device Sequence Number: 1
• Product Code: HTJ
• 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,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2016
• 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: 5032793
• Other Device ID Number: (01)10886982189943(10)5032793
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/12/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/14/2005
• 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: 53 YR