MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC DEPTH GAUGE FOR SMALL SCREWS; GAUGE, DEPTH

Model Number 319.09

Device Problem Material Twisted/Bent (2981)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Reporter is a synthes employee.Part: 319.090, lot: 2060, manufacturing site: (b)(4), release to warehouse date: 09.Oct.1998.Due to the age of more than 22 years of the complained device a wear or use related root cause is the most likely reason of the complained malfunction.Per franchise complaint product investigation procedure for complaints for which a non-manufacturing related probable cause has been identified no manufacturing record evaluation is required.Visual inspection: the depth gauge f/long-scr ø3.5 meas-range u (part #: 319.090; lot #: 2060) was returned and received at us customer quality (cq).Upon visual inspection, the needle component was bent and deformed that would have caused the functional failure of the device.The sleeve and body of two depth gauges with different lot numbers were received.A sleeve component (part #: 319.090, lot #: 2071) was received along with the body of a depth gauge (part #: 319.090, lot #: 2060).The possible explanation could be that the depth gauge (part #: 319.090, lot #: 2060) was taken apart for cleaning and sterilization and it appears that the customer reassembled the sleeve from one lot with the body of another.Since parts were misplaced, that should not affect the functionality or cause the bent needle condition thus would not contribute to the complaint condition.Functional test: a functional test was performed, and it was seen that the depth gauge was unable to slide freely.The body of the depth gauge was unable to move due to the bent needle.Device failure/defect identified? yes.Dimensional inspection: no dimensional inspection can be performed due to post-manufacturing damage.Document/specification review based on the date of manufacture the following drawings, the current and manufactured revision of drawings were reviewed.Depth gauge for long screws 3.5 mm, scale body, complete.Complaint confirmed? yes.Investigation conclusion: the complaint condition is confirmed as the needle component was bent, causing functional failure of the device.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.The root cause could be due to unintended forces applied to the device.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device was used for treatment, not diagnosis.

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that on an unknown date, that the forceps branch broke off.The broken part was removed and set aside.It was also noted by the head nurse that the depth gauge was not functioning.There was no reported consequence to the patient.This report involves one (1) depth gauge for small screws.This is report 2 of 2 for (b)(4).

• Brand Name: DEPTH GAUGE FOR SMALL SCREWS
• Type of Device: GAUGE, DEPTH
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): WERK BETTLACH (CH); muracherstrasse 3; bettlach 2544 ; SZ 2544
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 10642012
• MDR Text Key: 210243128
• Report Number: 2939274-2020-04544
• Device Sequence Number: 1
• Product Code: HTJ
• UDI-Device Identifier: 10886982189998
• UDI-Public: 10886982189998
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 10/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 319.09
• Device Catalogue Number: 319.090
• Device Lot Number: 2060
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/06/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/09/1998
• 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