MAUDE Adverse Event Report: SYNTHES BRANDYWINE TI SNAP-ON OPEN PARALLEL CONNECTOR 5.5MM/6.0MM; ORTHOSIS, PEDICL SPINAL FIXATION

Model Number	04.633.401
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device used for treatment, not diagnosis.Additional product codes: nkb, mnh, kwq, kwp.Subject device has been received and is currently in the evaluation process.Investigation is ongoing; no conclusion could be drawn as product is entering the complaint system.A device history record (dhr) review was performed.He report indicates that the: part# 04.633.401, lot# 6693444.Manufacturing site: (b)(6).Manufacturing date: 02-feb-2017.No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint action.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported that revision surgery was completed on (b)(6) 2017.The patient was implanted with synthes click x and pangea screws as well as depuy screws more than 5 years ago.The entire construct is from t-11 to l-5.The patient was then implanted with matrix connectors and rods to join together the synthes and depuy screws on (b)(6) 2017.The patient was involved in a car accident on an unknown date and presented with pain.He followed up with the surgeon in the beginning of (b)(6) and it was discovered that the connectors disconnected from the rods on the l-2 to l-3.The patient was revised with a synthes transitional rod and the locking caps were replaced.The surgery was completed successfully with no report of patient harm.There are 2 devices in this complaint concomitant devices reported: rods (part# 04.620.160, lot# 1526511, quantity 2), depuy spine screws (part # 1791-71-085, lot# bdht1sy, quantity 1).This report is 1 of 2 for (b)(4).
Additional Manufacturer Narrative
Product development investigation was completed.A device history record (dhr) review, device inspection, functional test and drawing review were performed as part of this investigation.The two connectors were received in the fully loosened position with surface wear consistent with implant and explant.When tested with the returned rods the connectors could each be attached and tightened.Once in the tightened position no movement was observed; the rods were retained as intended.The inner surfaces of the clamps were in good condition with only minor wear.Thus, as no functional issue was identified, the complaint condition for this device is unconfirmed and could not be replicated.Relevant drawings, reflecting the current and manufactured revision, were reviewed.Per the reviewed component drawings the inner cylindrical surfaces are bead blasted and are specified as ¿dimensions apply prior to finishing operation.¿ thus, dimensional inspection of the inner radius of the components to the print is not applicable for this feature.In lieu of a dimensional check, the devices were functionally tested with the mating rods and found to function as intended.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.No definitive root cause was able to be determined as circumstances surrounding the event are unknown and the complaint condition could not be replicated.It was reported that the patient was involved in a car accident on an unknown date and presented with pain.The forces experienced by the construct during this event and subsequently the impact on the complaint condition are unknown.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: TI SNAP-ON OPEN PARALLEL CONNECTOR 5.5MM/6.0MM
• Common Device Name: ORTHOSIS, PEDICL SPINAL FIXATION
• Manufacturer (Section D): SYNTHES BRANDYWINE; 1303 goshen parkway; west chester PA 19380
• MDR Report Key: 6924007
• Report Number: 2530088-2017-10296
• Device Sequence Number: 19029489
• Product Code: MNI
• UDI-Device Identifier: 10705034746753
• UDI-Public: (01)10705034746753(10)6693444
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K111358
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/15/2017

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
• Operator of Device: Health Professional
• Device Model Number: 04.633.401
• Device Catalogue Number: 04.633.401
• Device Lot Number: 6693444
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2017
• Initial Date Received by Manufacturer: 09/15/2017
• Supplement Date Received by Manufacturer: 11/10/2017
• Initial Report FDA Received Date: 10/06/2017
• Supplement Report FDA Received Date: 11/10/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR
• Patient Weight: 83