MAUDE Adverse Event Report: SYNTHES GMBH 2.8MM KIRSCHNER WIRE SPADE POINT 200MM; GUIDE, SURGICAL, INSTRUMENT

Catalog Number 03.108.005

Device Problems Material Deformation (2976); Scratched Material (3020)

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

Event Date 10/13/2021

Event Type  malfunction  

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2021, during a left lower limb reconstructive surgery, two (2) 2.8mm k-wires stripped and partially bent over their entire length and one (1) 2.0mm k-wire bent and stripped.No further information provided.This report is for one (1) 2.8mm kirschner wire spade point 200mm.This is report 1 of 3 for complaint (b)(4).

Manufacturer Narrative

Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.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.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.H10 additional narrative: h6 - codes updated to imdrf codes.Investigation summary: the complaint device was not received for investigation.A photo investigation was performed based on the image attached in the email in notes & attachments section of pc titled "source file - formato de novedades ktfm clínica noel.Colectivo 286417.Pdf".The image was reviewed, and the complaint condition is not confirmed.The image provided does not show any damage to the spade tip k-wire, therefore it cannot be confirmed that it is bent or scratched.A definitive assignable root cause could not be determined based on the provided information.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.During the investigation, no product design issues or discrepancies were observed (based on the image) that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.,background: procedure: left lower limb reconstructive surgery.Visual inspection: the k-wire ø2.8 w/spade point tip (p/n: 03.108.005 & lot #: 137p656) was returned and received at us cq.Upon visual inspection, it was observed that k-wire is little bent and had scratches all across the surface.No other issues were identified with the returned device.Document/specification review: based on the date of manufacture the following drawings, reflecting the current and manufactured revision were reviewed.Investigation conclusion: the complaint condition was confirmed for the device.No definitive root cause can be assigned based on the available information.During the investigation, no product design issues or discrepancies were observed.No manufacturing issues were noted during investigation.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Therefore, it has been determined that no corrective and/or preventive action is proposed.Device history lot : a manufacturing record evaluation was performed for the finished device 03.108.005 lot number 137p656, and no non-conformances were identified.Device history review : a manufacturing record evaluation was performed for the finished device 03.108.005 lot number 137p656, and no non-conformances were identified.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: 2.8MM KIRSCHNER WIRE SPADE POINT 200MM
• Type of Device: GUIDE, SURGICAL, INSTRUMENT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK BALSTHAL (CH); dornacherstrasse 20; balsthal 4710 ; SZ 4710
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 12775185
• MDR Text Key: 284829815
• Report Number: 8030965-2021-09379
• Device Sequence Number: 1
• Product Code: FZX
• UDI-Device Identifier: 07611819847255
• UDI-Public: (01)07611819847255
• Combination Product (y/n): N
• Reporter Country Code: CO
• 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: 10/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.108.005
• Device Lot Number: 137P656
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/29/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/05/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: K-WIRE Ø2 L280 SST; K-WIRE Ø2.8 W/SPADE POINT TIP
• Patient Sex: Female