MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC DEPTH GAUGE FOR 2.0/2.4 AND 2.7 SCREWS; GAUGE, DEPTH

Model Number 03.111.005

Device Problem Mechanical Problem (1384)

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

Event Type  malfunction  

Event Description

It was reported that, after inspection of the back up instruments, these were set aside for complaints.No patient involvement.This report is for one (1) depth gauge for 2.0mm/2.4mm and 2.7mm screws.This is report 3 of 7 for complaint (b)(4).

Manufacturer Narrative

Additional narrative: reporter is a synthes employee.(b)(6) 2021.Part # 03.111.005 lot # 8935213 release to warehouse date: (b)(6), 2014 manufacturer: hagendorf no ncr's were generated during production.Part: 03.111.005 lot: 3740500 manufacturing site: hagendorf supplier: n/a release to warehouse date: august 25, 2011 expiration date: n/a 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 2.0/2.4 and 2.7 screws (product code: 03.111.005, lot number: 8935213) was returned to customer quality (cq) west chester for investigation.The measuring needle part of the depth gauge was bent.No other issues were identified.Device/defect identified: yes document /specification review: based on the date of manufacture, the current and manufactured revisions of drawing were reviewed.Depth gauge for screws 2.0/2.4/2.7 dimensional inspection: diameter of the measuring tip: measured dimension, conforming measuring device used: caliper complaint confirmed: complaint can be confirmed based on the available information.Conclusion: the needle of the depth gauge was bent, hence the complaint was confirmed.A definitive root cause was not determined during investigation.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.

• Brand Name: DEPTH GAUGE FOR 2.0/2.4 AND 2.7 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 HÄGENDORF (CH); im bifang 6; haegendorf 4614 ; SZ 4614
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 13060980
• MDR Text Key: 288210909
• Report Number: 2939274-2021-07192
• Device Sequence Number: 1
• Product Code: HTJ
• UDI-Device Identifier: 10886982072078
• UDI-Public: (01)10886982072078
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: 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: 12/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 03.111.005
• Device Catalogue Number: 03.111.005
• Device Lot Number: 8935213
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/15/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/11/2014
• 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
• Treatment: 3.5 VA LCKNG SCR SLF-TPNG/SD/85; BENDING IRON FOR 2.7MM & 3.5MM PLATES; CANN CONNECTING SCREW FOR STD INSRT H≤ CANNULATED 2.5MM HEXAGONAL SCREWDRIVER; DEPTH GAUGE FOR LCKNG SCRS TO 100; DEPTH GAUGE FOR LCKNG SCRS TO 100; EXTRACTION SCR FOR TI FEM & TIB NAIL; GD BLK 2.7/3.5 VA ANTLAT DSTL TIB PL/RT; SCRDRIVERSHAFT-HEX-LRG Ø3.5 L165 F/QC; SCREWDRIVER, HEXAGONAL, SMALL, WITH HOLDING SLEEVE; SDDRIVE SCREWDRIVER SHAFT T8 105MM; SHARP HOOK; SMALL HEXAGONAL SCREWDRIVER SHAFT; UNK - SCREWDRIVERS