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); Material Fragmentation (1261)

Patient Problem No Patient Involvement (2645)

Event Date 11/02/2015

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional narrative: device is an instrument and is not implanted/explanted.The subject device is expected to be returned to the synthes manufacturer for evaluation.A service history record review was attempted for the subject device but could not be completed because the device is a lot-controlled item.The manufacture date of this item is 22-feb-2007.The source of the manufacture date is the release to warehouse date.The service history evaluation is unconfirmed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 tip broke of the depth gauge for 1.3mm and 1.5mm screws after the case when the sterile processing department was washing the device.There was no patient or surgical involvement.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

(b)(4).Service & repair evaluation: the customer reported the tip broke off.The repair technician reported ¿tip broken¿ as the reason for repair.The item is not repairable.The cause of the issue is unknown.The item will be forwarded to the complaint handling unit for further evaluation.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.

• 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: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5234291
• MDR Text Key: 31572222
• Report Number: 2530088-2015-10696
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 11/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Service and Testing Personnel
• Device Catalogue Number: 319.004
• Device Lot Number: 5460699
• Other Device ID Number: (01)10886982189936(10)5460699
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/19/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/22/2007
• 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