MAUDE Adverse Event Report: SYNTHES GMBH UNK - GUIDE/COMPRESSION/K-WIRES; WIRE, SURGICAL

Device Problems Difficult to Advance (2920); Material Deformation (2976)

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

Event Date 10/21/2022

Event Type  malfunction  

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.This report is for an unknown guide/compression/k-wires: trauma/unknown lot.Part and lot numbers are unknown; udi number is unknown.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Initial reporter occupation: reporter is a j&j employee.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 japan as follows: it was reported that on (b)(6) 2022, the patient underwent pediatric entropion osteotomy for coxa with the products in question.When inserting a 2.8 mm guidewire, the surgeon used the instrument in question, but there is an abnormal rubbing noise with the instrument when inserting the guidewire.Here was no tension on the guide wire, and when it was about 3 cm in, it would not advance and could not be pulled out.The guidewire became jammed in the instrument, and the surgeon forcibly removed the instrument and guidewire from the bone.The instrument became unusable, so he changed to a small standard, inserted a guide wire, and applied a plate, but the small was too small for the bone, so he changed again to a large standard.Since the instrument was not available, a drill guide with screws was attached to the plate as a substitute for the instrument, and the guide wire was inserted.The surgery was completed successfully with a 40-minute delay.There was a deformation observed at the tip of the instrument hole.It was confirmed by x-ray that there were no pieces left in the patient¿s body.The was no problem with bone fixation due to the use of an alternative product.The patient was reported as stable.No further information is available.This report involves one unk - guide/compression/k-wires: trauma.This is report 2 of 2 for (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.H3, h4, h6: the product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that the unk - guide/compression/k-wires had drilling marks along the surface and is slightly deformed across the mid-shaft.It is possible that the guidewire got cold-welded to the insertion hole of the aiming block.A dimensional inspection was performed for the unk - guide/compression/k-wires and met specifications.A functional test was performed, the guidewire was intended to be removed using forceps, however, the devices remained stuck and could not be disassembled, this is most likely due to the cold-welded condition inside the block.The complaint condition was able to be replicated.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 condition of the unk - guide/compression/k-wires would contribute to the complained device issue.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.Drawing/specifications reviewed? yes, reviewed.Dimensional inspection: since product code and lot number are not available, dimensional inspection was performed based on specifications of the 357.039 guidewire ø2.8 w/thread-tip w/trocar l35 as it has the same diameter as the one mentioned in the event description.The results were determined to be conforming.Device history lot a manufacturing record evaluation cannot be performed since lot number is unknown.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.D10: concomitant therapy date is (b)(6) 2022.

• Brand Name: UNK - GUIDE/COMPRESSION/K-WIRES
• Type of Device: WIRE, SURGICAL
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 15779730
• MDR Text Key: 307296819
• Report Number: 8030965-2022-09669
• Device Sequence Number: 1
• Product Code: LRN
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: AIMING BLOCK F/SCR Ø5 F/LCP PAED-HIPPL; UNK - DRILL BITS: TRAUMA; UNK - PLATES: TRAUMA; UNK - SCREWS: TRAUMA