MAUDE Adverse Event Report: SYNTHES BRANDYWINE DEPTH GAUGE FOR 2.7MM & SMALL SCREWS; GAUGE, DEPTH

Catalog Number 319.04

Device Problem Material Fragmentation (1261)

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

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.(b)(4) ¿ partial (b)(4) lot number unknown.Device is an instrument and is not implanted/explanted.A service and repair record review was attempted for the subject device; however, without a lot number the records cannot be traced.The service history evaluation is unconfirmed.A service and repair evaluation was performed for the subject device.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 synthes complaint handling unit for additional investigation.The service and repair evaluation was confirmed.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 hook pin on the depth gauge for 2.7mm and small screws broke off during a veterinary procedure on an unknown date.There was an approximate five minute surgical delay due to the reported event.There was no adverse effect to the animal patient.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

The year in the date of part return was reported in error as 2016.The device was received on december 31, 2015.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.

Manufacturer Narrative

Service history review: part 319.04, lot: 5414994: no service history review can be performed as this is a lot controlled item.The manufacture date of this item is january 05, 2007.The source of the manufacture date is the release to warehouse date.The service history evaluation is unconfirmed.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

Product investigation summary: one of the following was received: depth gauge - part 319.04 / lot 5414994.The returned depth gauge was received disassembled.The hooked probe was broken off the graduated slider body and was not returned.The missing subcomponent is approximately 70mm in length.The balance of the device is functionally undamaged with minor scratches and marks consistent with regular use and sterilization.The exact cause of the complaint condition could not be determined; but it is likely that the excessive force was applied on the device, possibly during sterile processing, causing the probe to weaken and then break off during use.A visual inspection and drawing review were performed as part of this investigation.No product design issues or discrepancies were observed.This complaint is confirmed.The device is used to determine what length of 2.7mm and 3.5mm screws are required for implantation and are part of the small fragment instrument and implant sets for locking compression plate wrist fusion and cannulated pediatric osteotomy system.The relevant drawings for the device(s) were reviewed.Relevant features/dimensions were inspected and found to be within specifications.No drawing issues or discrepancies were noted.The design was determined to be suitable for the intended use when employed and maintained as recommended.The exact cause of the complaint condition could not be determined; but it is likely that the excessive force was applied on the device, possibly during sterile processing, causing the probe to weaken and then break off during use.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 2.7MM & SMALL 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: 5355131
• MDR Text Key: 35493469
• Report Number: 2520274-2016-10114
• 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,Followup,Followup
• Report Date: 12/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 319.04
• Device Lot Number: 5414994
• Other Device ID Number: (01)10886982189974(10)5414994
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/30/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/17/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/05/2007
• 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