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

Catalog Number UNK - GUIDE/COMPRESSION/K-WIRE

Device Problem Device-Device Incompatibility (2919)

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

Event Date 05/10/2022

Event Type  malfunction  

Event Description

Device report from depuy synthes reports an event in japan as follows: it was reported that on (b)(6) 2022, the patient underwent the open reduction internal fixation with the tibial nail advanced (tna) for the transverse fracture of the diaphyseal tibia.The patient had good bone quality.The surgeon placed the knee in mild flexion to avoid the risk of interference between the nail and the locking screw.When the surgeon determined the entry point of the nail, he could not insert the guide wire because the insertion angle of the guide wire was 15 to 20 degrees instead of the ideal angle 10 degrees.After reaming the medullary canal, the surgeon inserted the nail with the hammer.The nail may have been deformed due to load on the nail while inserting the nail with the hammer because the shape of the nail and the shape of the bone in the open wound were different.The locking screw interfered with the nail hole while inserting the distal locking screw.The surgeon tightened the lock on the insertion handle firmly again.The surgeon could insert the locking screw in the proximal nail hole (central hole) without interference.The surgeon tried to insert the distal locking screw into the nail hole again; however, the locking screw interfered with the nail hole again.Although the locking screw interfered with the nail hole, the locking screw passed through the nail hole after hammering the drill.Therefore, the surgeon inserted the distal locking screw with the drill.The surgery was completed successfully within thirty (30) minutes delay.No further information is available.This report is for one (1) unknown guide wire.This is report 2 of 4 for complaint (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.Additional narrative: pma/510k: this report is for an unknown guide wire/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k number is unknown.Device available for evaluation: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Device evaluated by mfr: without a lot number the device history records review could not be completed.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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: 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.H10: correction narrative: d4; the catalog was inadvertently left blank on the initial report; and has been updated to reflect the correct information.

• Brand Name: UNK - GUIDE/COMPRESSION/K-WIRES
• Type of Device: WIRE, SURGICAL
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kate karberg ; 1302 wrights lane east; west chester, PA 19380 ; 8472871282
• MDR Report Key: 14629794
• MDR Text Key: 303159901
• Report Number: 8030965-2022-03752
• 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: Physician
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK - GUIDE/COMPRESSION/K-WIRE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: INSERT-HANDLE RADIOLUC MED.; UNK - DRILL BITS: TRAUMA.; UNK - IMPACTION INSTRUMENTS: HAMMER/MALLET: TRAUMA.; UNK - NAILS: TIBIAL.; UNK - SCREWS: NAIL DISTAL LOCKING.; UNK - SCREWS: NAIL PROXIMAL LOCKING.
• Patient Age: 24 YR
• Patient Sex: Male