MAUDE Adverse Event Report: SYNTHES USA TI PARALLEL CONNECTOR 5.0MM/6.0MM; PROSTHESIS, RIB REPLACEMENT

Catalog Number 04.641.015

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Sedation (2368)

Event Date 08/12/2015

Event Type  Injury  

Manufacturer Narrative

(b)(6).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 while resetting/replacing a left hook during a scheduled revision, it was discovered that the right hook implant was broken below the titanium parallel connector and plowing through the bone.The hook was difficult to remove as device was embedded in the patient's bone.Surgery time was prolonged by thirty to forty-five (30-45) minutes.Patient status is reported as okay.The original date of implantation is unknown.This is report 2 of 2 for (b)(4).

• Brand Name: TI PARALLEL CONNECTOR 5.0MM/6.0MM
• Type of Device: PROSTHESIS, RIB REPLACEMENT
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5049687
• MDR Text Key: 24874641
• Report Number: 2520274-2015-15629
• Device Sequence Number: 1
• Product Code: MDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK142587
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Report Date: 08/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 04.641.015
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/24/2015
• 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 Age: 17 YR
• Patient Weight: 41