MAUDE Adverse Event Report: SYNTHES GMBH 2.0MM TI MATRIXMANDIBLE LOCKING SCREW SLF-TPNG 6MM; PLATE, BONE

Catalog Number 04.503.606.01S

Device Problem Device-Device Incompatibility (2919)

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

Event Date 04/20/2021

Event Type  malfunction  

Manufacturer Narrative

A product investigation was conducted.The product was returned to us cq for evaluation.The us cq team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that lock scr ø2 self-tap l6 tan the screw is stripped on the threads and the hex is deformed.There was foreign debris on the screw which might be blood.The dimensional inspection was not performed due to post manufacturing damage.The functional test cannot be performed as the device was received by itself, but the alleged will not hold condition can be confirmed stripped thread condition might be the reason.The stripped and deformed condition of the screw was consistent with a random component failure that may have been caused by exposure to unintended forces.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed of the lock scr ø2 self-tap l6 tan.Although no definitive root-cause can be determined it¿s possible the device experienced unintended forces, there is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.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.A device history record (dhr) review was conducted: part: 04.503.606.01s.Lot: 80p2204.Manufacturing site: (b)(4).Release to warehouse date: 14 december 2020.Expiry date: 01 december 2030.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 during an open reduction internal fixation (orif) procedure on (b)(6) 2021 to treat mandibular fracture, total six (6) screws were applied to a plate with the same screwdriver.Among them one screw was not able to be connected to the screwdriver at all.The procedure was completed with a less than thirty (30) minutes surgical delay.No further information is available.During manufacturer's investigation of the returned device on (b)(6), 2021 it was observed that the screw is stripped on the threads and the hex is deformed.This report is for one (1) 2.0mm ti matrixmandible locking screw slf-tpng 6mm.This is report 1 of 1 for complaint (b)(4).

• Brand Name: 2.0MM TI MATRIXMANDIBLE LOCKING SCREW SLF-TPNG 6MM
• Type of Device: PLATE, BONE
• 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: 12060542
• MDR Text Key: 258166115
• Report Number: 8030965-2021-05303
• Device Sequence Number: 1
• Product Code: JEY
• UDI-Device Identifier: 07611819939714
• UDI-Public: (01)07611819939714
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K063790
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.503.606.01S
• Device Lot Number: 80P2204
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/17/2021
• Initial Date FDA Received: 06/24/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/14/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1