MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH 5.5 EXP VERSE DI SET SCR; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Catalog Number 199721000S

Device Problem Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/06/2018

Event Type  Injury  

Manufacturer Narrative

Device is available for evaluation.Investigation will be conducted.Follow up will be filed with the investigation results.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Date j&j became aware: 06.04.2018.Date of event: (b)(6) 2018.Name of reporter: (b)(6).Hospital name: (b)(6) hospital.Surgeon: (b)(6).Hospital town: (b)(6).Product name: expedium verse correction key (x3) + unitized set screw (x1).Product code : 199721000s & 199721001s.Lot/batch/exp: not known.Did the event happen during a procedure? yes.Were you in the procedure at the time of the event? yes.Was the product being used in a clinical trial? no.Event outcome/how was it managed? the innies which were stripped/ skipped a thread were replaced with unitized set screws and successfully final tightened.Was there a patient impact or was the procedure extended greater than 30 minutes due to the failure? no.Has the reporter facility indicated there may be legal action? no.Is the product available for return? the hospital sent the innies for decontamination- provided they¿re returned from cssd yes.Please give a detailed explanation of the event: the procedure was a neuromuscular scoliosis correction.Mr (b)(6) completed insertion of the rod (titanium), the correction manoeuvre and upon final tightening the correction keys were slipping/jumping a thread meaning they couldn¿t be final tightened when using the torque limiting handle and castle tightener.This happened on 4 screws in the construct.After this had happened once mr (b)(6) inserted the correction keys at the apex through, a quick stick and the issue persisted.It should be highlighted that the correction keys were inserted in a manner whereby load sharing was utilized, thus ensuring there wasn¿t excessive load placed on the correction keys at the apex.To resolve the issue mr (b)(6) removed the faulty correction keys and replaced them with unitized set screws.This allowed mr (b)(6) to final tighten all set screws in the construct.Wear debris/stripping was clear on inspection of the correction keys following removal.

Manufacturer Narrative

Product complaint # (b)(4).Device was not returned for evaluation.A review of the device history record could not be performed as the lot number is unknown.All complaint trends will be evaluated as a part of the depuy spine monthly complaint review meeting.Without the return of the device, we are unable to confirm the reported issue or identify the root cause.As no systemic trends were found, this complaint file will be closed with no further action required.Should more information and/or the sample be provided at a later time, this complaint will be reopened and device evaluated.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 5.5 EXP VERSE DI SET SCR
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer (Section G): MEDOS INT SPINE; chemin blanc 38; le locle ; SZ
• Manufacturer Contact: jason busch ; 325 paramount drive; raynham, MA 02767 ; 5088808100
• MDR Report Key: 7473394
• MDR Text Key: 106955209
• Report Number: 1526439-2018-50430
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10705034466125
• UDI-Public: (01)10705034466125
• Combination Product (y/n): N
• PMA/PMN Number: K142185
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 199721000S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/18/2018
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other