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

Catalog Number	492.160S
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/27/2024
Type of Reportable Event	Serious Injury
Additional 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.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.
Event or Problem 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 a 1.6mm ti kirschner wire 150mm.This is report 10 of 10 for (b)(4).
Additional 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.H11 additional narrative: h3, h4, h6 investigation summary: product was not returned.Based on the information available, it has been determined that no corrective and 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 history review (dhr): part # 492.160s lot # 161l725 manufacturing site: werk selzach logistik release to warehouse date: 17.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: part: # 492.160 lot: # 4552p28 manufacturing site: balsthal release to warehouse date: 28-mar-2023 a manufacturing record evaluation was performed for the finished device 492.160 lot 4552p28 and no non-conformances were found that could have resulted in the complaint condition.H6 component codes: most relevant component code is g07002 (appropriate term/code not available) to capture no findings available due to no product returned.Corrected data: h10: related reports added.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
• Common Device Name: 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: 19070863
• Report Number: 8030965-2024-04696
• Device Sequence Number: 4732588
• Product Code: HTY
• UDI-Device Identifier: 20886982236255
• UDI-Public: (01)20886982236255
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup

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
• Operator of Device: Health Professional
• Device Catalogue Number: 492.160S
• Device Lot Number: 161L725
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/27/2024
• Supplement Date Received by Manufacturer: 05/14/2024
• Initial Report FDA Received Date: 04/09/2024
• Supplement Report FDA Received Date: 06/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/17/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: K-WIRE ø1.6 L150 TAV; LCP PROX-RADIUSPL2.4 F/RAD NECK SHAFT 2H; LCP PROX-RADIUSPL2.4 F/RAD NECK SHAFT 3H; LCP PROX-RADIUSPL2.4 F/RAD NECK SHAFT 4H; LCP PROX-RADIUSPL2.4 LE F/RAD HEAD RIM S; LCP PROX-RADIUSPL2.4 LE F/RAD HEAD RIM S; LCP PROX-RADIUSPL2.4 LE F/RAD HEAD RIM S; LCP PROX-RADIUSPL2.4 R F/RAD HEAD RIM SH; LCP PROX-RADIUSPL2.4 R F/RAD HEAD RIM SH; LCP PROX-RADIUSPL2.4 R F/RAD HEAD RIM SH; UNK - KITS/SETS
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown