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

Catalog Number 319.006

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.There was no reported patient involvement associated with the complained event.Device is an instrument and is not implanted/explanted.The subject device is expected to be returned to the synthes manufacturer for evaluation but has not yet been received.The investigation could not be completed; no conclusion could be drawn, as no product was received.A device history record review was performed for the subject device lot.Manufacturer: (b)(4).Date of manufacture/release to warehouse date: (b)(6) 2003.The review showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.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 depth gauge was found broken in two pieces in sterile processing.The measuring needle was broken off from the black handle.This was identified as instruments were being cleaned following a surgical procedure.There was no patient involvement at the time the broken device was identified, and no reported patient harm or surgical delay in the surgical procedure prior to being found broken.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Product investigation has been completed for the reported device.A device history record (dhr) review, visual inspection, and drawing review were performed as part of this investigation based on the provided picture.The depth gauge is shown in the provided picture with the proximal portion of the needle broken off where it connects to the calibrated body of the device.The distal pin is present and assembled.The distal portion of the needle component and the protection sleeve are not shown.The balance of the device shows surface wear consistent with use and which would not impair the function of the device.The part number and lot number are clearly visible.In conclusion, the complaint condition is confirmed and consistent with the reported condition.Replication of the complaint condition is not applicable as the device is already broken.This depth gauge is used for measuring 2.0mm and 2.4mm screws in various trauma (including veterinary) plating systems.It is listed in techniques guides for the distal radius, distal ulna, elbow system, forefoot/midfoot, distal fibula, distal humerus, clavicle, rotation correction plate system and vet mini fragment system.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.The material of the needle component (part # 319.006.3) is 316leh (l=low carbon, e=extra h=hard) 316 stainless steel (ss), which is an appropriate material for an instrument component of this type.Based on the investigation, the part was determined to be suitable for the intended use when employed and maintained as recommended.The exact cause of the complaint condition cannot be determined as the handling and use of the device over its approximately 13.5 year lifespan are unknown.However, the condition of the depth gauge is consistent with the result of a bending force applied to the needle portion of the depth gauge that is beyond the yield limit of the material.Based on the investigation, the part was determined to be suitable for the intended use when employed and maintained as recommended.There is a protection sleeve to protect the needle during transport and the outer body adds additional protection to the needle attachment point during use.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

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

Device was used for treatment, not diagnosis.Additional product investigation was completed upon receiving the device.The measuring needle and protection sleeve were not returned.The complaint condition is confirmed as the depth gauge is shown with the proximal portion of the needle broken off where it connects to the calibrated body of the device.The exact cause of the complaint condition cannot be determined as the handling and use of the device over its approximately 13.5 year lifespan are unknown.However, the condition of the depth gauge is consistent with the result of a bending force applied to the needle portion of the depth gauge that is beyond the yield limit of the material as well as inattentiveness during sterilization.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Device was used for treatment, not diagnosis.Date for mw 2530088-2017-10021 follow up# 3 was inadvertently reported as march 13, 2017.It should be march 10, 2017.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: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6261516
• MDR Text Key: 65210134
• Report Number: 2530088-2017-10021
• Device Sequence Number: 1
• Product Code: HTJ
• UDI-Device Identifier: 10886982189943
• UDI-Public: (01)10886982189943(10)4629645
• 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
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 12/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2017
• 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: 4629645
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/10/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/29/2003
• 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