MAUDE Adverse Event Report: SYNTHES GMBH 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

Event occurred on an unknown date in 2021.Reporter is a j&j employee.Investigation summary: visual inspection: the depth gauge f/long-scr ø3.5 meas-range u (part# 319.090,lot# 23p9504, qty #1) was received for investigation.Upon visual inspection, it is observed that the needle component of the device is bent.Thus, the complaint is being confirmed.Additionally, the nut does not tighten up correctly in order to lock the scale body.Device failure/ defect found? yes.Functional test: during functional test, it was noted that the nut does not tighten up correctly in order to lock the scale body, it keeps sliding freely.Can the complaint condition be replicated? yes, the complaint condition can be replicated during functional test.Complaint confirmed? yes.Investigation conclusion: the depth gauge f/long-scr ø3.5 meas-range u (part# 319.090,lot# 23p9504, qty #1) was received for investigation.Upon visual inspection, it is observed that the needle component of the device is bent.Thus, the complaint is being confirmed.Additionally, the nut does not tighten up in order to lock the scale body.No definitive root cause could be determined based on the provided information.During the investigation no unidentified product design/manufacturing issues or discrepancies were observed that may have contributed to the complaint condition.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 history lot: part: 319.090, lot: 23p9504, manufacturing site: (b)(4).Release to warehouse date: 18 february 2020.Expiry date: n/a.A manufacturing record evaluation was performed for the finished device lot and no non-conformances were identified.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 synthes reports an event in (b)(6) as follows: it was reported that on an unknown date, the depth gauge for small screws was defective.There was no patient consequence.There is no further information available.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): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• 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: 13176513
• MDR Text Key: 289267480
• Report Number: 8030965-2022-00138
• Device Sequence Number: 1
• Product Code: HTJ
• UDI-Device Identifier: 07611819020788
• UDI-Public: (01)07611819020788
• 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: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2022
• 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: 23P9504
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/22/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/18/2020
• 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