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

Catalog Number 319.04

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

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

(b)(6) reported the following event: it was reported that the measuring needle is broken and the collar is missing from the depth gauge.There was no report of patient or surgical involvement associated with the complaint event.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.Event date: unknown.Device is an instrument and is not implanted/explanted.The investigation could not be completed; no conclusion could be drawn, as no product was received.A service history record review has been requested.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: lot #8935221- no service history review can be performed as this is a lot controlled item.The manufacture date of this item is july 16, 2014.The source of the manufacture date is the release to warehouse date.Product investigation summary: one of the following was received: depth gauge (part 319.04 / lot 8935221).The returned depth gauge received assembled was completely disassembled.The nipple/collar is missing and was not returned, and the hooked needle has been broken off the slider body.The device does not appear to have any further damage.A visual inspection and drawing review were performed as part of this investigation.No product design issues or discrepancies were observed.The cause of this complaint condition cannot be determined, but it was most likely caused by inattentiveness during sterilization.This complaint is confirmed.The associated drawing for the device was reviewed.Relevant features/dimensions were inspected and found to be within specification.No drawing issues or discrepancies were noted.The design is adequate for its intended use and did not contribute to this complaint condition.No other issues were identified with the device.The design is adequate for its intended use, and it did not contribute to the complaint condition.Device is 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.

• Brand Name: DEPTH GAUGE FOR 2.7MM & SMALL SCREWS
• Type of Device: GAUGE,DEPTH
• Manufacturer (Section D): SYNTHES HAGENDORF; im bifang 6; hagendorf CO 80132 CH4; SZ 80132 CH46
• Manufacturer (Section G): SYNTHES HAGENDORF; im bifang 6; hagendorf CO 80132 CH4; SZ 80132 CH46
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4745963
• MDR Text Key: 5823449
• Report Number: 1719045-2015-10270
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2015
• 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: 8935221
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/27/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/16/2014
• 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