MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH UNKNOWN SCREWS

Device Problem Material Deformation (2976)

Patient Problem No Code Available (3191)

Event Date 01/23/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).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

The following was reported: see below.Please note that this item was not able to be decontaminated and risk if sterilised that may not be able to identify as the product.Please handle with care as this has body fluids on the item.Hospital name ¿ (b)(6).Surgeon ¿ (b)(6).Product name ¿ verse product code - 199721000s - correction key.X1 unitised set screw x3 1997210001s.This has not been decontaminated and hence not able to read lot number.Date of event - (b)(6) 2018.Is the product available for return? locking caps that failed to seat.Did the event happen during a procedure? yes.Were you in the procedure at the time of the event? yes.Was the product in a clinical trial? no.Event outcome/how was it managed? we tried alternative locking caps but didn¿t seat.The surgeons decided to leave one screw without a locking cap.Was there a patient impact or was the procedure extended greater than 15 minutes due to the failure? (if yes please tell us by how long the procedure was delayed) no.Has the reporter facility indicated there may be legal action? no.Please give a detailed explanation of the event? mr.(b)(6) had an ais patient.~ (b)(6) female.Screws went in beautifully.He used verse top and bottom and uniplanar at the apex as lumbar curve on concavity.Used a cocr rod to correct on concavity.He put a ck in at top and bottom.The second most distal screw seemed to cross thread as he inserted which resulted in damaging the inside of the tulip.During the reduction.The tabs could not withstand the force applied and resulted in cross threading.This resulted in frustration caused as he replaced with a unitised.The unitised would not seat in the head of the screw either.The quick stick was applied.He left this locking cap and reduced the uniplanar screws and corrected the deformity.Once this has been done the rod was fully seated and he tried to put another unitised into the tulip.I suggested to take the extended tabs off and use the verse clip on reducer.He did this and the unitised failed to seat.He decided to leave the screw without a nut.We need a detailed response to why this keeps occuring.Please can you provide this for me.

Manufacturer Narrative

Product complaint #
=
> (b)(4).Udi: (01)unavailable.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.

Manufacturer Narrative

Product complaint #
=
> (b)(4).

• Brand Name: UNKNOWN SCREWS
• Type of Device: UNKNOWN
• 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: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 8359594
• MDR Text Key: 136871722
• Report Number: 1526439-2019-51376
• Device Sequence Number: 1
• Product Code: KWP
• UDI-Public: (01)UNAVAILABLE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 03/22/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/23/2019
• Initial Date FDA Received: 02/21/2019
• Supplement Dates Manufacturer Received: 03/21/2019; 04/19/2019
• Supplement Dates FDA Received: 04/15/2019; 04/19/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 14 YR