MAUDE Adverse Event Report: SYNTHES GMBH TRAUMACEM(TM) V+ SYRINGE KIT- STERILE; DISPENSER, CEMENT

Catalog Number 03.702.150S

Device Problem Break (1069)

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

Event Date 09/17/2021

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no product was received; 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.

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 the tfna agmt surgery with the syringe in question.During the surgery, when the surgeon inserted the cement into the syringe, the syringe was broken.It was unknown if the surgery completed successfully.No further information is available.This complaint involves one (1) device.This report is for (1) traumacem(tm) v+ syringe kit- sterile.This report is 1 of 1 of (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.H3, h6: 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 one of the blue syringe was broken, and no other issues were identified with other the whole kit.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 due to unknown lot, the following documents were reviewed: body 1ml syringe assembly.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: TRAUMACEM(TM) V+ SYRINGE KIT- STERILE
• 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: 12639184
• MDR Text Key: 276636217
• Report Number: 8030965-2021-08720
• Device Sequence Number: 1
• Product Code: KIH
• 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,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 09/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.702.150S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/15/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: TRAUMA NEEDLE KIT Ø3.3 CANNUL W/SIDE-OPE; TRAUMACEM V+ CEMENT KIT 10 ML