MAUDE Adverse Event Report: SYNTHES BETTLACH DEPTH GAUGE FOR SMALL SCREWS; GAUGE, DEPTH

Catalog Number 319.09

Device Problem Break (1069)

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

Event Type  malfunction  

Manufacturer Narrative

Device used for treatment, not diagnosis.Patient information not available for reporting.Other udi: (b)(4).Implant and explant date: device is an instrument and is not implanted/explanted.Device is expected to be returned to synthes manufacturer for evaluation /investigation, but has yet to be received.Pma 510k#: unknown.Without a lot number, the device history record review and 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

Device report from synthes on an event in (b)(6) as follows: it was reported that during an intraoperative procedure on (b)(6) 2016, the scrub nurse noticed that the tip of the depth gauge for small screws was broken and was not functioning correctly.A peel pouched depth gauge was opened for the case.The surgery was successfully completed and there was no surgical delay reported.The patient status/outcome is unavailable.This complaint involves 1 device.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

A product development investigation was performed for the subject device.(b)(4) reported that during an intraoperative procedure, the scrub nurse noticed that the tip of the depth gauge for small screws was broken and was not functioning correctly.The returned device shows no evidence of a broken measuring hook.The measuring hook was found to be slightly bent; however, it is able to mate with the guide sleeve, headpiece and knurled cap appropriately and slides throughout the entire guide sleeve without issue.All components of the device show minor surface wear consistent with use, which does not impact functionality.The drawing associated with the returned guide sleeve (manufactured drawing for the slider assembly) does not match the returned guide sleeve, the returned guide sleeve and slider assembly were not paired at the time of manufacture and were likely assembled together during sterile processing.The length from the slider body to the inside of the hook was measured to be 129.98mm which is within the specification of 130mm +/- 0.3.The height of the measuring hook tip was measured to be 1.69mm which is within the specification of 1.8mm +0/-0.3mm.The design history was not found to impact the complaint condition.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.The returned parts were determined to be suitable for the intended use when employed.A device history record review was performed for the subject device lot number 8717901.Manufacturing location: (b)(4).Date of manufacture: jan 19, 2014.The review showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.No non-conformances were generated during the production of the subject device.The returned concomitant guide sleeve shows no evidence of having contributed to the event.Therefore, further investigation is not necessary.No definitive root cause was able to be determined.The complaint of a broken measuring hook tip was unable to be confirmed.The measuring hook was found to have a slight bend which was likely related to cumulative wear and rough handling of the device.There were no issues during the manufacture of this product that would contribute to this complaint condition.The design history was not found to impact the complaint condition.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.The returned parts were determined to be suitable for the intended use when employed.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 SMALL SCREWS
• Type of Device: GAUGE, DEPTH
• Manufacturer (Section D): SYNTHES BETTLACH; muracherstrasse 3; bettlach PA CH254 4; SZ CH2544
• Manufacturer (Section G): SYNTHES BETTLACH; muracherstrasse 3; bettlach CH254 4; SZ CH2544
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6139366
• MDR Text Key: 61303523
• Report Number: 2520274-2016-15543
• 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,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 319.09
• Device Lot Number: 8717901
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/22/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/19/2014
• 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