MAUDE Adverse Event Report: SYNTHES GMBH CORTSCR ø1.3 SELF-TAP L9 TAN; PLATE, FIXATION, BONE

Catalog Number 04.130.009S

Device Problem Device-Device Incompatibility (2919)

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

Event Date 01/11/2024

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.H10 additional narrative: d2b: additional product code: hwc.D9: complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.E3: reporter is a j&j sales representative.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 Description

Device report from synthes reports an event in japan as follows: it was reported that on (b)(6) 2024, the patient underwent an orif for fifth metacarpal diaphyseal fracture.The locking screw was inserted but unlocked in a hole in the y-shaped plate.And then, the locking screw in question was tried to be inserted to another hole, and unlocked situation remained.Meanwhile, the unfitting hole was reattempted to be inserted by other screw, and locking was successful.The surgeon commented that the cause for the unlocked situation is likely the screw in question itself.The surgery was completed successfully without any surgical delay.Patient status, stable.No further information is available.2 items has been registered as impacted products for the screws.This is because it is unclear which lot of screws is the actual complaint item.The surgery was completed without any problems with implant fixation due to the use of an alternative.This report is for one (1)cortscr ã¸1.3 self-tap l9 tan.This is report 4 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.H3, h4, h6 investigation summary: 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 threads near the tip of the screw, cortscr ã¸1.3 self-tap l9 tan, were damaged and stripped.This is likely due to contact with another device, most likely a plate.A dimensional inspection was performed for the cortscr ã¸1.3 self-tap l9 tan and met specifications.An interactional test was unable to performed due to mating device was not received to asses the interaction.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The reported issue of not locking to the plate is not confirmed for the cortscr ã¸1.3 self-tap l9 tan as this is a cortex screw and is not intended to be locked to a plate.The cortex screw can be inserted through a plate hole and the observed damage to the tip of the screw is consistent with contact against the side of the plate hole during insertion.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.Dimensional inspection: feature: total length.Feature: shaft diameter.Specification: 9 mm +0.5mm / -0.0 mm.Specification: 1.3 mm / 1.35 mm max.Measured dimension: 9.43 mm (conforming).Measured dimension: 1.31 mm (conforming).Device history: a manufacturing record evaluation was performed for the finished device product code: 04.130.009s.Lot no :810p159.It was electronically reviewed and no nonconformances / manufacturing irregularities were identified during the manufacturing process.The product was released on: 18-may-2022.Manufacturing site: jabil grenchen.Expiry date:01-may-2032.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.H3, h6: the device has been received, the investigation is in progress, no conclusion could be drawn at the time of filing 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.

• Brand Name: CORTSCR ø1.3 SELF-TAP L9 TAN
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): JABIL GRENCHEN; solothurnerstrasse 186; grenchen CO 2540 ; SZ 2540
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 18596324
• MDR Text Key: 333972358
• Report Number: 8030965-2024-01473
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 10886982112262
• UDI-Public: (01)10886982112262
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K150099
• 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,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.130.009S
• Device Lot Number: 810P159
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/11/2024
• Initial Date FDA Received: 01/29/2024
• Supplement Dates Manufacturer Received: 02/28/2024; 03/20/2024
• Supplement Dates FDA Received: 03/14/2024; 03/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/18/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: LOCKING Y-PLATE 1.3 HE 3HO SHAFT 5HO L27; LOCKSCR ø1.3 SELF-TAP L9 TAN; LOCKSCR ø1.3 SELF-TAP L9 TAN
• Patient Sex: Female