MAUDE Adverse Event Report: SYNTHES GMBH SILICONE HNDL/QC ROTATING CAP; FORCEPS

Model Number 03.118.111

Device Problem No Apparent Adverse Event (3189)

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

Event Date 01/01/2022

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Depuy synthese is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthese has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthese or its employees that the report constitutes an admission that the device, depuy synthese, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Investigation summary: the following device was received as blind unit for the following products: 03.043.029; 2023519 319.006; h521672 319.006; a4gj568 03.010.523; 9570803 03.010.523; l759640 03.010.523; 31p5810 03.010.523; 9850771 03.010.491; h884724 03.037.017; 9764853 393.10; unk 03.033.001; l750728 03.118.111; t981020 no additional information is known.However, it couldn¿t be associated with a complaint or any other existing record.This complaint involves six (6) devices.,: the subject device has been received at depuy synthese for evaluation.The depuy synthese team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that silicone hndl/qc rotating cap was broken from the cap of the tip.The broken fragment was not returned for examination.No other issues were found.A dimensional inspection for the silicone hndl/qc rotating cap was not performed as is not applicable to the complaint condition.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to unintended forces.As part of depuy synthese quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed as the observed condition of the silicone hndl/qc rotating cap would contribute to the complained device issue.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.Drawing/specifications reviewed the following source controlled drawings reflecting the current and manufactured revisions were reviewed: dimensional inspection: n/a device history lot part # 03.118.111 synthese lot #t981020 supplier lot # t981020 release to warehouse date:(b)(6) 2013, supplier : synthese tuttlingen no ncrs were generated during production.Device history batch, null, device history review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.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

It was reported that the visual analysis of the returned sample revealed that the following device was received as blind unit for the following products: visual analysis of the returned sample revealed that silicone hndl/qc rotating cap was broken from the cap of the tip.The broken fragment was not returned for examination.No other issues were found.No additional information is known.However, it couldn't be associated with a complaint or any other existing record.This complaint involves six (6) devices.This report is for one (1) silicone hndl/qc rotating cap this is report 6 of 6 for complaint (b)(4).

• Brand Name: SILICONE HNDL/QC ROTATING CAP
• Type of Device: FORCEPS
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES TUTTLINGEN; unter hasslen 5; tuttlingen CO 78532 ; GM 78532
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 16482385
• MDR Text Key: 311142900
• Report Number: 8030965-2023-02650
• Device Sequence Number: 1
• Product Code: HTD
• UDI-Device Identifier: 10886982073686
• UDI-Public: (01)10886982073686
• 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: Health Professional,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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 03.118.111
• Device Catalogue Number: 03.118.111
• Device Lot Number: T981020
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/01/2023
• Initial Date FDA Received: 03/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/28/2013
• 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: AIM-ARM RADIOLUC; BLADE/SCREW GUIDE SLEEVE; DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS; DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS; DRIVING CAP/THREADED; DRIVING CAP/THREADED; DRIVING CAP/THREADED; DRIVING CAP/THREADED; LONG SCALPEL HANDLE; RADIOLUCENT INSERTION HANDLE FRN; UNIVERSAL CHUCK WITH T-HANDLE