MAUDE Adverse Event Report: SYNTHES GMBH DPS HAERTOE CCI STD KIT 1.25 K-WIRE/ -S; STAPLE, FIXATION, BONE

Model Number	STANDARD
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	01/01/2022
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.H3, h4, h6: 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 or Problem Description
It was reported that on an unknown date, a sales representative tried to use the new product compliant feature but couldn¿t send a photo.The sales representative visited the surgeon to see why the surgeon had not used the products in a couple months.The surgeon used the hammer toe cci roughly 5 or 6 times in a 2-month period.However, i stopped because he did not have great post-op results, even with ideal inter-operative visualization.One was large, and the other two were standard sizes.The patient experienced implant failure with one implant.Two implants have been coded as npi based on the images and information provided.There is no evidence that the implants have been removed.If additional information is received, the determination will be reassessed.This report is for one (1)dps haertoe cci std kit 1.25 k-wire/ -s.This is report 1 of 1 for complaint (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.H10 additional narrative: the photo was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device from the photo.Visual analysis of the photos revealed that were no damage or defect with the dps haertoe cci std kit 1.25 k-wire/ -s, x-ray revealed a non-compress between the intermediate and proximal phalanges and did not have a great post op results.Image does not show enough information available to classify the health impact.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was not confirmed for dps haertoe cci std kit 1.25 k-wire/ -s.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.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.If information is obtained that was not available for this medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: DPS HAERTOE CCI STD KIT 1.25 K-WIRE/ -S
• Common Device Name: STAPLE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 16864607
• Report Number: 8030965-2023-05685
• Device Sequence Number: 5386071
• Product Code: JDR
• UDI-Device Identifier: 00810633022047
• UDI-Public: (01)00810633022047
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K191463
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• 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 Model Number: STANDARD
• Device Catalogue Number: 46.239.001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/18/2023
• Supplement Date Received by Manufacturer: 05/09/2023
• Initial Report FDA Received Date: 05/03/2023
• Supplement Report FDA Received Date: 05/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown