MAUDE Adverse Event Report: SYNTHES USA 3.5MM CORTEX SCREW SELF-TAPPING 42MM; PLATE, FIXATION, BONE

Catalog Number 204.842

Device Problem Bent (1059)

Patient Problems Pain (1994); Loss of Range of Motion (2032); Swelling (2091); Weakness (2145); Impaired Healing (2378)

Event Type  Injury  

Manufacturer Narrative

Patient exact age is unknown; reported as in his (b)(6).This report is for an unknown lag screw/unknown lot.Part and lot numbers are unknown; udi number is unknown.Revision procedure occurred in (b)(6) 2013 however the screw broke and could not be completely removed.Complainant part is not expected to be returned for manufacturer review/investigation.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.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

It was reported that a patient underwent surgery on (b)(6) 2012 for a left hallux valgus second hammer toe.The procedure included the insertion of two 3.5 mm lag screws in to the patient's left foot.On (b)(6) 2012, patient was in great pain and went to the emergency room (er).On (b)(6) 2012, the patient came in for a post-operative x-ray and both screws were visible and appeared unbent and uncorrupted.On (b)(6) 2012, a third x-ray was performed which showed both screws appearing to be uncorrupted and straight.On (b)(6) 2012, the patient started weight bearing on the foot with a walking boot.The patient also used a crutch or cane due to pain while weight bearing.Patient started physical therapy (pt), which caused him extreme pain.On (b)(6) 2012 a fourth x-ray was performed that showed the screws had begun to bend.By (b)(6) 2013, the patient continued to have significant pain, swelling and limited utility regarding his left foot.A fifth x-ray on (b)(6) 2013 clearly indicated that one of the screws had a more pronounced bend and that one of the screws was in fact broken.The x-ray also showed that bone fusion had never occurred.Between (b)(6) 2013, the patient continued to experience pain and difficulty walking.In (b)(6) 2013, patient had revision surgery to remove the broken screw.According to the report, the broken screw could not be removed as bone has grown around it.Following the revision surgery, patient returned for a follow up and learned that his foot had become infected.X-rays of the patient's left foot were taken in (b)(6) 2013.To date, patient experiences a modified gait and limited use of his foot due to pain and weakness.In (b)(6) 2016, it was noted that bone fusion had not occurred.This report is for an unknown lag screw.This is report 2 of 2 for (b)(4).

Manufacturer Narrative

This report is for an unknown 3.5mm cortex screw.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

This report is for an unknown 3.5mm cortex screw.

Manufacturer Narrative

Device was used for treatment, not diagnosis.(b)(4).It is unknown if the bent device was explanted during revision procedure in (b)(6) 2013.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Device was used for treatment, not diagnosis.Common device name: initially reported as screw, fixation, bone and corrected to plate, fixation, bone; device product code: initially reported as hwc and corrected to hrs.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

(b)(6) 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

Additional product code: hwc and jds.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

The patient has had three foot surgeries: two (2) breaks and one (1) broken screw ¿ broke in 2013 (broke piece of metal).According to the progress notes: on (b)(6) 2016, the patient still wearing left boot and using two crutches; on (b)(6) 2016 the patient using two crutches and left boot; on (b)(6) 2016 the patient off crutches and will move to a shoe.

Manufacturer Narrative

Investigation summary: the product was not returned and as no lot number was provided, neither a dhr nor an investigation could not be performed.Investigation update september 13th 2017.It was reported that a patient underwent surgery on (b)(6) 2012 for a left hallux valgus second hammer toe.The procedure included the insertion of two 3.5 mm cortex screws in to the patient¿s left foot.On (b)(6) 2012, patient was in great pain and went to the emergency room (er).On (b)(6) 2012, the patient came in for a post-operative x-ray and both screws were visible and appeared unbent and uncorrupted.On (b)(6) 2012, a third x-ray was performed which showed both screws appearing to be uncorrupted and straight.Patient started physical therapy (pt), which caused him extreme pain.On (b)(6) 2012 a fourth x-ray was performed that showed the screws had begun to bend.By (b)(6) of 2013, the patient continued to have significant pain, swelling and limited utility regarding his left foot.A fifth x-ray on (b)(6) 2013 clearly indicated that one of the screws had a more pronounced bend and that one of the screws was in fact broken.The x-ray also showed that bone fusion had never occurred.In (b)(6) of 2013, patient had revision surgery to remove the broken screw.Part #: 204.850, lot #: unk ¿ this device was reported to have bent and then broke postoperatively.Part #: 204.842, lot #: unk ¿ this device was reported to have bent postoperatively.Neither device has been returned; however, x-ray images of the devices have been provided.The x-rays from (b)(6) 2012 and (b)(6) 2012 show no visible deformation of the screws.The x-rays from (b)(6) 2012 show minor bending of both screws.The x-rays from (b)(6) of 2013 show additional bending to one of the screws; however, no obvious breakage exists.The x-rays from (b)(6) 2013 show a broken screw fragment retained in the patient.The other screw was completely removed.The bent screw and the broken screw could be confirmed based on the returned x-rays.Replication is not applicable to this complaint condition.The following drawings were reviewed: 204_810 the devices were implanted (b)(6) 2012 and revision n was released in (b)(6) of 2012 meaning the devices would have been manufactured to revision m or prior.As the devices were not returned further review against the product drawing could not be conducted.Device 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

Updated information: file entitled: medical record summary.01jun2017: additional information received in the form of chiropractic progress notes.Chiropractic center added as additional complainant.

• Brand Name: 3.5MM CORTEX SCREW SELF-TAPPING 42MM
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5813392
• MDR Text Key: 50176014
• Report Number: 2520274-2016-13573
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131186
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 07/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 204.842
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/14/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 95