MAUDE Adverse Event Report: SYNTHES GMBH TRAUMA SYRING KIT 4*1 ML 2*2 ML; DISPENSER, CEMENT

Catalog Number 03.702.150S

Device Problem Break (1069)

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

Event Date 08/12/2021

Event Type  malfunction  

Manufacturer Narrative

Additional narrative: complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.Reporter is a j&j sales representative.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 on (b)(6) 2021, the patient underwent surgery for trochanteric fracture with the cement in question.After mixing of the cement, the surgeon couldn¿t inject the cement into the stop-cock.The surgeon continued to inject the cement with a strong force, and after the clicking sound the surgeon was able to inject the cement into the stop-cock.The surgeon connected the white syringe and tried to fill with the cement.When the surgeon removed the syringe after filling with the second white syringe, the tip of the syringe was broken.The surgeon couldn¿t connect the syringe because the tip got stuck in the stop-cock, and the surgeon gave up using the cement.Procedure was completed successfully without any surgical delay.There was also a way to open the lid and inject the cement directly into the syringe, but the doctor decided not to use cement because it has a problem from the beginning.This report is for one (1) traumacem(tm) v+ syringe kit - sterile.This is report 1 of 3 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.H10 additional narrative: d10 h3, h6: part: 03.702.150s.Lot: 1022578.Manufacturing site: selzach.Supplier: symatese device release to warehouse date: march 23, 2021.Expiration date: february 01, 2026.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.The product was returned to us customer quality (cq) for evaluation.The us cq team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that trauma syring kit 4*1 ml 2*2 ml the tip of the syringe was broken, and no other issues were identified.The dimensional inspection was not performed due to post manufacturing damage.The observed condition trauma syring kit 4*1 ml 2*2 ml in the device 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 as the observed broken condition of the trauma syring kit 4*1 ml 2*2 ml.While no definitive root cause could be determined, it is probable that the trauma syring kit 4*1 ml 2*2 ml was broken due to the unintended forces.There was no indication that a design or manufacturing issue contributed to the complaint.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 drawing reflecting the current and manufacture revision was reviewed: - trauma syringe kit, 4 x 1ml, 2 x 2ml 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.H5.

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: h3, h6: the device was 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.

• 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 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12449052
• MDR Text Key: 271130513
• Report Number: 8030965-2021-07609
• Device Sequence Number: 1
• Product Code: KIH
• UDI-Device Identifier: 07611819476523
• UDI-Public: (01)07611819476523
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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 Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 08/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.702.150S
• Device Lot Number: 1022578
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/03/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/23/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: TRAUMACEM V+ CEMENT KIT 10 ML; TRAUMACEM V+ CEMENT KIT 10 ML; TRAUMACEM V+ CEMENT KIT 10 ML; TRAUMACEM V+ CEMENT KIT 10 ML