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

Catalog Number 319.090

Device Problem Material Integrity Problem (2978)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/01/2021

Event Type  malfunction  

Manufacturer Narrative

Reporter is a synthes employee.Part: 319.090, lot: 3l22958, manufacturing site: (b)(4), supplier: synthes (b)(4), release to warehouse date: 26 february 2019.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.Visual inspection: the complaint device depth gauge for long screws (part no- 319.090, lot no- 3l22958) was returned to customer quality (cq) west chester for investigation.The depth gauge needle was bent and deformed.No other issues were identified.Device failure/defect identified: yes.Service and repair evaluation: the customer reported the depth gauge was defective and it was difficult to grab the opposite side of bone.The repair technician reported the gauge was bent.The cause of the issue and the reason for repair is bent.The item will be scrapped.The item cannot be repaired per the inspection sheet and will be forwarded to customer quality.The evaluation was confirmed.Document/specification review: based on the date of manufacture, the current and manufactured version of drawings were reviewed.Depth gauge for long screws, (current) and rev a (manufactured).Dimensional inspection: dimensional inspection was not performed as it is evident that the depth gauge needle was bent.Complaint confirmed: yes, the complaint condition can be confirmed based on the available information.Investigation conclusion: the depth gauge needle was bent and deformed.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/ specification review.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.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 (b)(6) reports an event as follows: it was reported that on an unknown date that it was difficult to grab the opposite side of bone and hook to it with the depth guage.This report is for one (1) depth gauge for small screws.This is report 1 of 1 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 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12751938
• MDR Text Key: 280142850
• Report Number: 2939274-2021-06489
• Device Sequence Number: 1
• Product Code: HTJ
• 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: 10/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 319.090
• Device Lot Number: 3L22958
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/12/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/26/2019
• 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