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

Catalog Number 319.04

Device Problem Incorrect Measurement (1383)

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

Event Type  malfunction  

Manufacturer Narrative

Device used in a veterinary case - no patient information will be reported.Device is an instrument and is not implanted/explanted.No service history review can be performed as part number 319.04 with lot number(s) 5519612 is a lot/batch controlled item.The manufacture date of this item is may 21, 2007.The source of the manufacture date is the release to warehouse date.The service history review is unconfirmed.Part 319.04, synthes lot 5519612: release to warehouse date: may 21, 2007.Supplier: (b)(4).No non-conformance reports were generated during production.Review of the device history records showed that there were no issues during the manufacturing of this product that would contribute to this complaint condition.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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.

Event Description

This is a veterinary complaint.It was reported that routine post-operative radiographs revealed improper screw lengths were used on multiple veterinary patients that underwent unspecified surgical procedures.The depth gauge was checked and found to be inaccurate.The measurement was off by approximately two millimeters.It was reported that there were no surgical delays or other medical interventions required.All procedures were completed successfully and the patients were healing.Concomitant devices reported: screw (part unknown, lot unknown, quantity unknown).This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.A product development investigation was performed for the depth gauge (part number 319.04, lot number 5519612).The subject device was returned with the complaint condition stating the device was received intact with minimal cosmetic damage and wear present.There is a strip of blue tape on the outer body, the nipple/nose, and the internal slider body.The device was dimensionally inspected and found to be conforming to specifications.There were no issues found with the returned device.The complaint condition was unconfirmed.The device was received by service & repair, and the device was found to be slightly worn.Device was unable to be repaired and was sent to customer quality (cq).A service history review was unable to be performed since this is a lot/batch controlled device.Drawings were reviewed.No drawing issues or discrepancies were noted.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.Calipers were used for all dimensional inspections/measurements a review of risk assessment (dcrm) found the risk specific to the complaint condition adequately addressed.The condition of the returned device does agree with the complaint description.Whether the complaint condition for this device can be replicated is not applicable for this condition.The root cause of the complaint condition is unknown as no issues were found with the returned device as the device was conforming to specifications.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 was performed for part # 319.04, lot # 5519612.The customer reported the gauge did not work properly.The repair technician reported the tip of the gauge appeared to be worn.Worn out 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 to customer quality.The evaluation was confirmed.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: mark vornheder ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6026119
• MDR Text Key: 57324641
• Report Number: 2530088-2016-10288
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 09/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2016
• 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: 5519612
• Other Device ID Number: (01)10886982189974(10)5519612
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/16/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/21/2007
• 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
• Treatment: UNKNOWN QUANTITY OF UNKNOWN SCREWS