MAUDE Adverse Event Report: SYNTHES GMBH TRAUMA SYRING KIT 4*1 ML ADAPT 2.3; DISPENSER, CEMENT

Catalog Number 03.702.140S

Device Problem Failure to Eject (4010)

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

Event Date 09/14/2021

Event Type  malfunction  

Manufacturer Narrative

Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Reporter is a j&j employee.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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 a procedure on (b)(6) 2021, when passing the cement and syringes in its preparation, it was not possible to recharge the syringes.The cement set very quickly, between the nozzle and the connector and there was something that prevented the passage.The faucet was opened and closed and even after that the syringes could not be recharged.An attempt was made to pass a kirshrer nail through the transfer cap and it did not pass.The cement turned viscous immediately between the passage of the cement and its respective mixture.No further information provided.This report is for one (1) trauma syring kit 4*1 ml adapt 2.3.This is report 1 of 2 for complaint (b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, 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.The subject device has been received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, 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.H10 additional narrative: h6 - codes updated to imdrf codes.Visual inspection: the trauma syring kit 4*1 ml adapt 2.3 (p/n: (b)(6), lot #: 8102545) was returned and received at us cq.Upon visual inspection the cement was hardened inside the kit.No other issues were identified with the returned device.Functional test: as the cement has hardened inside kit the functional assessment cannot be performed.However the retain samples testing was performed by the vendor, osartis.The result of the testing revealed no deviations; hence the a faulty product was excluded.See attached "abschlussbericht rm2021-93.Pdf" for full report from the vendor.Dimensional inspection: no dimensional inspection can be performed due to post-manufacturing damage.Furthermore, the device relevant dimensions cannot be checked for dimensional accuracy, because of the design of the device.Document/specification review based on the date of manufacture, the current and manufactured revision of drawings/documents were reviewed trauma syringe kit se_501031 rev ag (current & manufactured) no discrepancies or issues were identified.Investigation conclusion the complaint condition was confirmed for the trauma syring kit 4*1 ml adapt 2.3 (p/n: (b)(6), lot #: 8102545).The cement inside the mixer was observed to be hardened which could have been due to cement exposed to the external environmental conditions.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.The potential cause of the hardening of the cement could be traced to user not following promptly the instructions.Based on the investigation findings, it has been determined that no corrective and/or preventive 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 - a manufacturing record evaluation was performed for the finished article 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.

• Type of Device: DISPENSER, CEMENT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES SELZACH; bohackerweg 5; selzach 2545 ; SZ 2545
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 12636768
• MDR Text Key: 279004974
• Report Number: 8030965-2021-08694
• Device Sequence Number: 1
• Product Code: KIH
• UDI-Device Identifier: 07611819642829
• UDI-Public: (01)07611819642829
• Combination Product (y/n): N
• Reporter Country Code: CO
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 09/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2023
• Device Catalogue Number: 03.702.140S
• Device Lot Number: 8102545
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2021
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/15/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/15/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: TRAUMACEM V+ CEMENT KIT 10 ML.