MAUDE Adverse Event Report: SYNTHES GMBH 1.6MM TI KIRSCHNER WIRE 150MM; PIN, FIXATION, SMOOTH

Catalog Number 492.160S

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Insufficient Information (4580)

Event Date 03/27/2024

Event Type  Injury  

Event Description

Device report from france reports an event as follows: it was reported that patient was to undergo an unknown procedure on (b)(6) 2024.During the intervention, the surgeon noticed that the implants were missing from the orthokit.The patient was under anesthesia and had to be woken up.The intervention was postponed to (b)(6) 2024.The ordered kit was entered in the system and shipped.However, this kit contains only instrumentation.The implants are in a different kit which was not shipped to the customer.It seems that the local helping tool for the booking of orthokit missed some information; the helping tool was not updated with the correct information.The implant kit was shipped to the customer on (b)(6) 2024.This report is for one 1.6mm ti kirschner wire 150mm for (b)(4).This is complaint is linked to pc-001576402 for additional impacted products.

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: d9: complainant part is not expected to be returned for manufacturer review/investigation.E3: reporter is a synthes employee.H3, h6: 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.

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.Part # 492.160s, lot # 161l276, manufacturing site: werk selzach logistik, release to warehouse date: 13.April.2023, expiration date: 01.April.2033, supplier: (b)(4).A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.Non-sterile part: # 492.160, lot: # 4553p71, manufacturing site: balsthal, release to warehouse date: 28-mar-2023.A manufacturing record evaluation was performed for the finished device 492.160 lot 4553p71 and a reference to a non-conformance was found.The found non-conformance reference was created to correct the non-ppe documents in the routers at hägendorf and balsthal sites.This is not related to any manufacturing defect for device 492.160 lot 4553p71, and not related to the complaint condition described.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: 1.6MM TI KIRSCHNER WIRE 150MM
• Type of Device: PIN, FIXATION, SMOOTH
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES SELZACH; bohackerweg 5; selzach 2545 ; SZ 2545
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 19143658
• MDR Text Key: 340599653
• Report Number: 8030965-2024-05277
• Device Sequence Number: 1
• Product Code: HTY
• UDI-Device Identifier: 20886982236255
• UDI-Public: (01)20886982236255
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 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?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 492.160S
• Device Lot Number: 161L276
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/19/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/13/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: K-WIRE ø1.6 L150 TAV; K-WIRE ø1.6 L150 TAV; K-WIRE ø1.6 L150 TAV; K-WIRE ø1.6 L150 TAV; K-WIRE ø1.6 L150 TAV; K-WIRE ø1.6 L150 TAV; K-WIRE ø1.6 L150 TAV; K-WIRE ø1.6 L150 TAV; K-WIRE ø1.6 L150 TAV
• Patient Outcome(s): Required Intervention