MAUDE Adverse Event Report: SYNTHES BRANDYWINE TI S-HOOK-RIGHT; PROSTHESIS, RIB REPLACEMENT

Catalog Number 497.258

Device Problems Break (1069); Difficult to Remove (1528)

Patient Problems Failure of Implant (1924); Sedation (2368)

Event Date 08/12/2015

Event Type  Injury  

Manufacturer Narrative

Exact weight reported as (b)(6).The investigation could not be completed; no conclusion could be drawn, as no product was received.Device history record review: manufacturing date: 17april2012.Part 497.258, lot 6879222 did not contain any non-conformance reports or any anomalies.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 condition.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 1 of 2 for com-(b)(4).

• Brand Name: TI S-HOOK-RIGHT
• Type of Device: PROSTHESIS, RIB REPLACEMENT
• Manufacturer (Section D): SYNTHES BRANDYWINE; 1303 goshen parkway; west chester PA 19380
• Manufacturer (Section G): SYNTHES BRANDYWINE; 1303 goshen parkway; west chester PA 19380
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5049646
• MDR Text Key: 24879859
• Report Number: 2530088-2015-10576
• 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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 497.258
• Device Lot Number: 6879222
• 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
• Date Device Manufactured: 04/17/2012
• 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