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

Catalog Number 319.004

Device Problems Break (1069); Component Missing (2306)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

No reported patient or surgical involvement.Device is an instrument and is not implanted or explanted.The complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Investigation could not be completed and no conclusion could be drawn as no device was returned device history record review: manufacturing location: (b)(4) - manufacturing date: december 26, 2007.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 this 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 reported that a review of field equipment was conducted on an unknown date during which issues were discovered with instrumentation.The probes on three (3) depth gauges for 2.0mm and 2.4mm screws were broken off while the probe tip hook of a depth gauge for 1.3mm and 1.5mm screws was missing.Additionally, a flexible shaft connecter had fallen apart.No reported patient or surgical involvement.All five (5) parts were assessed for reportability.Based upon provided information, only the broken devices have been deemed reportable incidents.This report is 4 of 4 for (b)(4).

Manufacturer Narrative

A product investigation was completed: four depth gauges (3 of part 319.006 and 1 of oarat 319.004) were received for investigation.The 319.006 depth gauges all have the hooked metal probe broken off at the base of the black graduated body, while part 319.004 has only the tip of the needle broken off.It is unknown what caused the damage to each device.This complaint is confirmed.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.The material of the needle probe component (part 319.006.03 and 319.004.3) is extra hard 316ss, which is an appropriate material for an instrument component of this type.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 depth gauge damage is unknown.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 1.3MM AND 1.5MM 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: 5744932
• MDR Text Key: 48030389
• Report Number: 2530088-2016-10172
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2016
• 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: 4360386
• Other Device ID Number: (01)10886982189936(10)4360386
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/22/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/26/2007
• 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