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

Catalog Number 319.010

Device Problem Material Integrity Problem (2978)

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

Event Date 12/23/2020

Event Type  malfunction  

Manufacturer Narrative

During the visual inspection, the tip of the returned device was found worn and deformed.Moreover, there are multiple signs of use.The observed damage is consistent with the reported complaint condition as such the complaint condition can be confirmed.All features related to the reported complaint condition were reviewed and no other issues were identified.According to the visual inspection per guidance provided, it is determined that the reusable instrument is worn from repeated use and servicing; therefore, further investigation for the reported complaint device is not required.During the investigation, no product design or manufacturing issues were observed that may have contributed to the complaint condition; therefore, further corrective and/or preventive action is not required.The root cause was identified during the performed cq evaluation and therefore the in the investigation flow listed remaining investigation steps are not required.As part of our quality process all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Device history lot: product code 319.010, lot#: 2656550, manufacturing site: (b)(4), release to warehouse date: 25.Oct.2010.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Device history batch: null.Device history review: null.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 (b)(6) 2020, the patient underwent the open reduction internal fixation surgery for the elbow fracture with the depth gauge in question.During the surgery, the surgeon found that the tip of the depth gauge caught was bad.The surgery was completed successfully without any surgical delay.No further information is available.This report is for one (1) depth gauge for 2.7mm & small screws.This is report 1 of 1 for (b)(4).

• Brand Name: DEPTH GAUGE FOR 2.7MM & 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 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 11344345
• MDR Text Key: 232572781
• Report Number: 8030965-2021-01119
• Device Sequence Number: 1
• Product Code: HTJ
• UDI-Device Identifier: 07611819020733
• UDI-Public: (01)07611819020733
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 319.010
• Device Lot Number: 2656550
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/18/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/25/2010
• 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